Oxygen SaturationNCT05683210
Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding of Preterm Infants
A study testing Cup feeding and Bottle feeding in people with Oxygen Saturation and Heart Rate, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The research was planned in a randomized controlled experimental design to determine the effects of the cup and bottle used during the first oral feeding on physiological characteristics and feeding performance in preterm infants. Read more about this study
- Who is it for?
- Ages 30 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation, Heart Rate, Nutritional Status
- What is being tested?
- Cup feeding and Bottle feeding
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2021to 20 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Having diagnostic criteria for severe bronchopulmonary dysplasia (≥30% O2 requirement and/or positive pressure requirement at the 36th postmenstrual week or at discharge in preterm infants with a gestational age of <32 weeks; ≥30% O2 requirement or positive pressure requirement at the 56th postnatal day or at discharge in preterm infants with a gestational age of ≥32 weeks)
- Having an anomaly such as cleft palate, cleft lip
- Having gastrointestinal, neurological or genetic disease (NEC, IVH, hydrocephalus, asphyxia, Down syndrome, short bowel syndrome, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding on Physiological Characteristics and Feeding Performance of Preterm Intants
The research was planned in a randomized controlled experimental design to determine the effects of the cup and bottle used during the first oral feeding on physiological characteristics and feeding performance in preterm infants. The research was carried out between January 2021 and February 2022 at the Neonatal Intensive Care Unit of Göztepe Süleyman Yalçın City Hospital. Research data were obtained from preterm infants who were born before 34 weeks of gestation, appropriate to selection of study group criterias and hospitalized in the neonatal intensive care unit. A total of 80 babies in the sample group were randomly assigned to the experimental (bottle) and control (cup) groups. Oxygen saturation, heart rate, feeding performance and test weight before, during and after feeding of preterms in both groups were compared. There was no statistically significantly difference between the experimental and control groups in terms of oxygen saturation and heart rate.
Read the detailed description
The coordination of sucking, swallowing and breathing is necessary for the preterm infant to be effectively and safely fed by the oral route. Although the sucking motion begins in the 27-28th week, the coordination of sucking, swallowing, and breathing appears in the 32-34th week. Introducing oral feeding to preterm infants is recommended by sucking the mother's breast when they are ready for oral feeding. Preterm infants are fed through complementary feeding methods such as a bottle, spoon, dropper, cup, and finger feeding until they reach the condition to meet their nutritional needs by sucking the mother's breast.
Bottle feeding is one of the nutritive sucking methods commonly used in both preterm and term infants worldwide. When the mother is unable to breastfeed or breast milk is not available, preterm infants can be fed with a bottle. Bottle feeding contributes to effective feeding and helps the infant to relax by meeting the sucking reflex. Cup feeding has been used in developed and developing countries for many years to feed premature infants and those with low birth weights. Cup feeding is a simple, practical, effective, and low cost method that can be used in infants who can swallow but are unable to suck well enough to be fed completely from the mother's breast, and in cases where an alternative such as a gastric catheter or a bottle is required for feeding.
Studies that compared bottle and cup feeding reported that the swallowing performance of preterm infants fed with a bottle was better, the length of hospital stay was longer in preterm infants fed with a cup, and the duration of feeding was longer in preterms fed with a cup compared to those fed with a bottle, the rate of breastfeeding after discharge was higher in those fed with a cup, no significant difference was found in weight gain, but the quantity of food intake was less and the rate of food spillage was higher in preterm infants fed with a cup compared to those fed with a bottle. For all of these reasons, bottle feeding is reported to be a safer and more appropriate method.
This randomised controlled experimental study was carried out to compare the effect of cup and bottle feeding on physiological characteristics and feeding performance in preterm infants born at or below the 34th gestational week. A power analysis was used to determine. The study included a total of 80 preterms, 40 preterms for each group. The parents of preterm infants who met the inclusion criteria granted their written and verbal consent.
Experimental Group
The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. No invasive intervention or care was provided for the infant to rest for 1 hour before feeding. Data were collected during working hours (08.00-16.00) to establish common physical environment conditions for each infant. Bottles and teats to be used during feeding were sterilised with a steam steriliser. The heart rate and oxygen saturation of the infants were recorded 30 minutes before the time of feeding, and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. All findings were recorded on the "Feeding Monitoring Form".
After all steps before feeding were completed and recorded, the infant was loosely wrapped with a soft cloth and started to be fed by being held only by the researcher in order to prevent the effect of different feeding practices of the nurses on the study. As soon as feeding was initiated, a stopwatch was activated by another nurse who worked in the clinic in order to avoid any bias, and the feeding time was maintained not to exceed 30 minutes to prevent the infant from getting tired. During the feeding period, heart rate and oxygen saturation were continuously recorded. The infants in the experimental group were fed with a bottle. The teat of the feeding bottle was selected to be smaller in size, softer and with a smaller hole than the teat of the term infant and suitable for preterm infants. The same brand and model of bottle and its teat were used for each infant. All infants in this group were fed in a semi-elevated side-lying position, as it was more similar to the position in which the infant suckled the mother's breast. The infant's lips were tapped with the bottle teat for stimulating to feed, and when the infant opened his/her mouth and drooped his/her tongue, the teat of the bottle was put into his/her mouth. During feeding, stimulant behaviours such as pushing the bottle back and forth and swirling the bottle in the mouth were avoided in order to allow the infant to suck faster and accelerate the flow. The time elapsed from when the infant started to suck the bottle until he/she released the bottle from his/her mouth was considered as the feeding phase.
Physiological and behavioural signs of stress (throwing the head backwards, trying to push the bottle and cup away with the tongue, arching back, grimacing, fanning the fingers, rapid and loud breathing, aspiration, coughing and trying to swallow quickly, desaturation (<90), apnoea, tachycardia, bradycardia and colour change) were observed in all bottle and cup-fed infants during feeding. Also, signs of fatigue (i.e., decreased muscle tone, inability to maintain flexion posture, reduced sucking-swallowing activity, spilling milk out of the mouth) were observed in both groups.
In case of signs of stress and fatigue, feeding was interrupted for a short time and the infant was allowed to rest. When the infant was physiologically (HR of 120-160/min, SpO2 ≥90) and behaviourally ready, feeding was resumed and the infant was prevented from getting tired during feeding and actively participated in feeding. Feeding time was limited to 30 minutes, including the infants' resting times. When the infant was no longer sucking, another nurse who worked in the clinic stopped the stopwatch in order to prevent bias and the feeding phase was terminated. The feeding process was completed at the end of 30 minutes even if the infant did not take all of the food.
After feeding, the body weight of the infants was measured only with the diaper on and the test weight was determined. Test weighing is a technique used to measure the amount of nutrition of the infant, in which the infant is weighed before and after feeding without undressing if the infant is dressed and without changing the diaper if the infant is diapered, and 1 gram corresponds to 1 ml of breast milk. After the procedure, the infant was put in the incubator in a right-side position to facilitate gastric discharge. The infant was followed up for 30 minutes after the end of the feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values. The recorded data were classified into pre-feeding, feeding and post-feeding periods, entered into a computer environment, and averaged. The amount of food taken by the infant during the 30-minute feeding was recorded, and if the infant was unable to take the entire amount of food prescribed by the physician, he/she took the remaining amount with an orogastric catheter after the post-feeding measurements were finished.
Control Group
The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. No invasive intervention or care was provided for the infant to rest for 1 hour before feeding. Data were collected during working hours (08.00-16.00) to establish common physical environment conditions for each infant. The cup to be used during feeding was sterilised with a steam steriliser. The heart rate and oxygen saturation of the infants in both groups were recorded 30 minutes before the time of feeding and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. All findings were recorded on the "Feeding Monitoring Form".
After all steps before feeding were completed and recorded, the infant was loosely swaddled with a soft cloth and started to be fed by being held only by the researcher in order to prevent the effect of different feeding practices of the nurses on the study. As soon as feeding was initiated, a stopwatch was activated by another nurse who worked in the clinic in order to avoid any bias, and the feeding time was maintained not to exceed 30 minutes in order to prevent the infant from getting tired. During the feeding period, heart rate and oxygen saturation were continuously recorded. The infants in the control group were fed with a cup. The cups currently used in the clinic for feeding were selected in a size suitable for the preterm infant so that they would not damage the lips, palate and tongue. During feeding, all infants in this group were placed in semi-elevated supine position. The cup was inserted into the infant's lips and elevated until the milk reached the infant's mouth. The position of the infant was adjusted so that when the milk reached the tongue, the infant would start foraging, dip his/her tongue into the milk by dimpling and slurp the milk with his/her tongue through a negative pressure, swallow as much as he/she wants and leave the rest back to the cup. The cup was not raised to allow the infant to slurp the milk more quickly and the milk was not poured into his/her mouth, so that the infant was given complete control over the feeding. The stopwatch was activated when the infant began to drink the milk from the cup, and the stopwatch was stopped when the infant no longer slurped the milk, and the feeding process was completed. In case of signs of stress and fatigue, feeding was interrupted for a short time and the infant was allowed to rest. When the infant was physiologically (HR of 120-160/min, SpO2 ≥90) and behaviourally ready, feeding was resumed and the infant was prevented from getting tired during feeding and actively participated in feeding. Feeding time was limited to 30 minutes, including the infants' resting times. When the infant was no longer sucking, another nurse who worked in the clinic stopped the stopwatch in order to prevent bias and the feeding phase was terminated. The feeding process was completed at the end of 30 minutes even if the infant did not take all of the food. After feeding, the body weight of the infants was measured with only the diaper on and the test weight was determined. After the procedure, the infant was put in the incubator in a right-side position to facilitate gastric discharge. The infant was followed up for 30 minutes after the end of feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values. The recorded data were classified into pre-feeding, feeding, and post-feeding periods, entered into a computer environment, and averaged. The amount of food taken by the infant during the 30-minute feeding period was recorded, and if the infant was unable to take in the entire amount of food prescribed by the physician, he/she took the remaining amount with an orogastric catheter after the post-feeding measurements were finished.
- Conditions
- Oxygen Saturation, Heart Rate, Nutritional Status
- Being tested
- Cup feeding, Bottle feeding
- Keywords
- preterm infants, oxygen saturation, heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cup feedingBehavioural
The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. The infants' heart rate and oxygen saturation were recorded 30 minutes before feeding, and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. Feeding time was limited to 30 minutes, including the infants' resting time. When the infant was no longer sucking, the stopwatch was stopped, and the feeding phase was terminated. The feeding process was completed at the end of 30 minutes even if the infant did not take all of the food. The infant was followed up for 30 minutes after the end of feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values.
Bottle feedingBehavioural
The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. The infants' heart rate and oxygen saturation were recorded 30 minutes before feeding, and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. During the feeding period, heart rate and oxygen saturation were continuously recorded. Feeding time was limited to 30 minutes, including the infants' resting time. When the infant was no longer sucking, the stopwatch was stopped, and the feeding phase was terminated. The infant was followed up for 30 minutes after the end of the feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values.
| Study group | Role | What they receive |
|---|---|---|
| Cup feeding | Experimental | The infants in the control group were fed with a cup. During feeding, all infants in this group were placed in semi-elevated supine position. The position of the infant was adjusted so that when the milk reached the tongue, the infant would start foraging, dip his/her tongue into the milk by dimpling and slurp the milk with his/her tongue through a negative pressure, swallow as much as he/she wants and leave the rest back to the cup. The stopwatch was activated when the infant began to drink the milk from the cup, and the stopwatch was stopped when the infant no longer slurped the milk, and the feeding process was completed. When the infant was physiologically (HR of 120-160/min, SpO2 ≥90) and behaviourally ready, feeding was resumed and the infant was prevented from getting tired during feeding and actively participated in feeding. Feeding time was limited to 30 minutes in either group, including the infants' resting time. Receives: Behavioral: Cup feeding |
| Bottle feeding | Experimental | The infants in the experimental group were fed with a bottle. The teat of the feeding bottle was selected to be smaller in size, softer and with a smaller hole than the teat of the term infant and suitable for preterm infants. The same brand and model of bottle and teat were used for each infant. All infants in this group were fed in a semi-elevated side-lying position, as it was more similar to the position in which the infant suckled the mother's breast. The infant's lips were tapped with the bottle teat for stimulating to feed, and when the infant opened his/her mouth and drooped his/her tongue, the teat of the bottle was put into his/her mouth. The time elapsed from when the infant started to suck the bottle until he/she released the bottle from his/her mouth was considered as the feeding phase. Receives: Behavioral: Bottle feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding Status
In order to assess the feeding status of the infant, his/her time of feeding and the amount of nutrient he/she receives in a minute will be calculated. In order to determine his/her time of feeding, a phone chronometer will be started as soon as he/she begins feeding and it will be stopped when feeding is over. All infants in experimantal group and control group will be fed with a slow-flow bottle branded Avent which is designed for premature infants. It will be calculated how much (cc) of the total amount of nutrient ordered by the doctor the infant receives. The total amount of nutrient received by the infant will be divided into the time of feeding and thus the amount of nutrient received in a minute (cc) will be calculated.
Measured: maximum 30 minutes
Secondary outcomes (2)
Heart Rate
The "Covidien Nellcor Pulse Oximeter Bedside" device and its probe were employed to determine the heart rate of preterm infants before, during, and after feeding. Alert limits for heart rate were set as 120-160/min on the device. The heart rate of preterm infants in the experimental and control groups began to be recorded 30 minutes before feeding and continued to be recorded during the feeding and for 30 minutes after the end of the feeding.
Measured: All babies in experimental group and control group will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 30 minutes before the feeding time, during the feeding and at 30 minutes after the feeding.
Oxygen Saturation
The "Covidien Nellcor Pulse Oximeter Bedside" device and its probe were employed to determine oxygen saturation in preterm infants before, during and after feeding. The oxygen saturation below 90% for more than one second was considered as desaturation in the study. The oxygen saturation of preterm infants in the experimental and control groups began to be recorded 30 minutes before feeding and continued to be recorded during the feeding and for 30 minutes after the end of the feeding.
Measured: All babies in experimental group and control group will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 30 minutes before the feeding time, during the feeding and at 30 minutes after the feeding.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start13 Jan 2021
- Primary completion20 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Musaoglu, Istanbul University - Cerrahpasa
- Investigators
- Duygu Gözen, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683210
- Sponsor's protocol ID
- cup and bottle feeding
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding on Physiological Characteristics and Feeding Performance of Preterm Intants
- ClinicalTrials.gov ID
- NCT05683210
- Acronym / sponsor ID
- cup and bottle feeding
- Conditions
- Oxygen Saturation, Heart Rate, Nutritional Status
- Keywords
- preterm infants, oxygen saturation, heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research was planned in a randomized controlled experimental design to determine the effects of the cup and bottle used during the first oral feeding on physiological characteristics and feeding performance in preterm infants. The research was carried out between January 2021 and February 2022 at the Neonatal Intensive Care Unit of Göztepe Süleyman Yalçın City Hospital. Research data were obtained from preterm infants who were born before 34 weeks of gestation, appropriate to selection of study group criterias and hospitalized in the neonatal intensive care unit. A total of 80 babies in the sample group were randomly assigned to the experimental (bottle) and control (cup) groups. Oxygen saturation, heart rate, feeding performance and test weight before, during and after feeding of preterms in both groups were compared. There was no statistically significantly difference between the experimental and control groups in terms of oxygen saturation and heart rate.
Detailed description
The coordination of sucking, swallowing and breathing is necessary for the preterm infant to be effectively and safely fed by the oral route. Although the sucking motion begins in the 27-28th week, the coordination of sucking, swallowing, and breathing appears in the 32-34th week. Introducing oral feeding to preterm infants is recommended by sucking the mother's breast when they are ready for oral feeding. Preterm infants are fed through complementary feeding methods such as a bottle, spoon, dropper, cup, and finger feeding until they reach the condition to meet their nutritional needs by sucking the mother's breast.
Bottle feeding is one of the nutritive sucking methods commonly used in both preterm and term infants worldwide. When the mother is unable to breastfeed or breast milk is not available, preterm infants can be fed with a bottle. Bottle feeding contributes to effective feeding and helps the infant to relax by meeting the sucking reflex. Cup feeding has been used in developed and developing countries for many years to feed premature infants and those with low birth weights. Cup feeding is a simple, practical, effective, and low cost method that can be used in infants who can swallow but are unable to suck well enough to be fed completely from the mother's breast, and in cases where an alternative such as a gastric catheter or a bottle is required for feeding.
Studies that compared bottle and cup feeding reported that the swallowing performance of preterm infants fed with a bottle was better, the length of hospital stay was longer in preterm infants fed with a cup, and the duration of feeding was longer in preterms fed with a cup compared to those fed with a bottle, the rate of breastfeeding after discharge was higher in those fed with a cup, no significant difference was found in weight gain, but the quantity of food intake was less and the rate of food spillage was higher in preterm infants fed with a cup compared to those fed with a bottle. For all of these reasons, bottle feeding is reported to be a safer and more appropriate method.
This randomised controlled experimental study was carried out to compare the effect of cup and bottle feeding on physiological characteristics and feeding performance in preterm infants born at or below the 34th gestational week. A power analysis was used to determine. The study included a total of 80 preterms, 40 preterms for each group. The parents of preterm infants who met the inclusion criteria granted their written and verbal consent.
Experimental Group
The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. No invasive intervention or care was provided for the infant to rest for 1 hour before feeding. Data were collected during working hours (08.00-16.00) to establish common physical environment conditions for each infant. Bottles and teats to be used during feeding were sterilised with a steam steriliser. The heart rate and oxygen saturation of the infants were recorded 30 minutes before the time of feeding, and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. All findings were recorded on the "Feeding Monitoring Form".
After all steps before feeding were completed and recorded, the infant was loosely wrapped with a soft cloth and started to be fed by being held only by the researcher in order to prevent the effect of different feeding practices of the nurses on the study. As soon as feeding was initiated, a stopwatch was activated by another nurse who worked in the clinic in order to avoid any bias, and the feeding time was maintained not to exceed 30 minutes to prevent the infant from getting tired. During the feeding period, heart rate and oxygen saturation were continuously recorded. The infants in the experimental group were fed with a bottle. The teat of the feeding bottle was selected to be smaller in size, softer and with a smaller hole than the teat of the term infant and suitable for preterm infants. The same brand and model of bottle and its teat were used for each infant. All infants in this group were fed in a semi-elevated side-lying position, as it was more similar to the position in which the infant suckled the mother's breast. The infant's lips were tapped with the bottle teat for stimulating to feed, and when the infant opened his/her mouth and drooped his/her tongue, the teat of the bottle was put into his/her mouth. During feeding, stimulant behaviours such as pushing the bottle back and forth and swirling the bottle in the mouth were avoided in order to allow the infant to suck faster and accelerate the flow. The time elapsed from when the infant started to suck the bottle until he/she released the bottle from his/her mouth was considered as the feeding phase.
Physiological and behavioural signs of stress (throwing the head backwards, trying to push the bottle and cup away with the tongue, arching back, grimacing, fanning the fingers, rapid and loud breathing, aspiration, coughing and trying to swallow quickly, desaturation (<90), apnoea, tachycardia, bradycardia and colour change) were observed in all bottle and cup-fed infants during feeding. Also, signs of fatigue (i.e., decreased muscle tone, inability to maintain flexion posture, reduced sucking-swallowing activity, spilling milk out of the mouth) were observed in both groups.
In case of signs of stress and fatigue, feeding was interrupted for a short time and the infant was allowed to rest. When the infant was physiologically (HR of 120-160/min, SpO2 ≥90) and behaviourally ready, feeding was resumed and the infant was prevented from getting tired during feeding and actively participated in feeding. Feeding time was limited to 30 minutes, including the infants' resting times. When the infant was no longer sucking, another nurse who worked in the clinic stopped the stopwatch in order to prevent bias and the feeding phase was terminated. The feeding process was completed at the end of 30 minutes even if the infant did not take all of the food.
After feeding, the body weight of the infants was measured only with the diaper on and the test weight was determined. Test weighing is a technique used to measure the amount of nutrition of the infant, in which the infant is weighed before and after feeding without undressing if the infant is dressed and without changing the diaper if the infant is diapered, and 1 gram corresponds to 1 ml of breast milk. After the procedure, the infant was put in the incubator in a right-side position to facilitate gastric discharge. The infant was followed up for 30 minutes after the end of the feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values. The recorded data were classified into pre-feeding, feeding and post-feeding periods, entered into a computer environment, and averaged. The amount of food taken by the infant during the 30-minute feeding was recorded, and if the infant was unable to take the entire amount of food prescribed by the physician, he/she took the remaining amount with an orogastric catheter after the post-feeding measurements were finished.
Control Group
The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. No invasive intervention or care was provided for the infant to rest for 1 hour before feeding. Data were collected during working hours (08.00-16.00) to establish common physical environment conditions for each infant. The cup to be used during feeding was sterilised with a steam steriliser. The heart rate and oxygen saturation of the infants in both groups were recorded 30 minutes before the time of feeding and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. All findings were recorded on the "Feeding Monitoring Form".
After all steps before feeding were completed and recorded, the infant was loosely swaddled with a soft cloth and started to be fed by being held only by the researcher in order to prevent the effect of different feeding practices of the nurses on the study. As soon as feeding was initiated, a stopwatch was activated by another nurse who worked in the clinic in order to avoid any bias, and the feeding time was maintained not to exceed 30 minutes in order to prevent the infant from getting tired. During the feeding period, heart rate and oxygen saturation were continuously recorded. The infants in the control group were fed with a cup. The cups currently used in the clinic for feeding were selected in a size suitable for the preterm infant so that they would not damage the lips, palate and tongue. During feeding, all infants in this group were placed in semi-elevated supine position. The cup was inserted into the infant's lips and elevated until the milk reached the infant's mouth. The position of the infant was adjusted so that when the milk reached the tongue, the infant would start foraging, dip his/her tongue into the milk by dimpling and slurp the milk with his/her tongue through a negative pressure, swallow as much as he/she wants and leave the rest back to the cup. The cup was not raised to allow the infant to slurp the milk more quickly and the milk was not poured into his/her mouth, so that the infant was given complete control over the feeding. The stopwatch was activated when the infant began to drink the milk from the cup, and the stopwatch was stopped when the infant no longer slurped the milk, and the feeding process was completed. In case of signs of stress and fatigue, feeding was interrupted for a short time and the infant was allowed to rest. When the infant was physiologically (HR of 120-160/min, SpO2 ≥90) and behaviourally ready, feeding was resumed and the infant was prevented from getting tired during feeding and actively participated in feeding. Feeding time was limited to 30 minutes, including the infants' resting times. When the infant was no longer sucking, another nurse who worked in the clinic stopped the stopwatch in order to prevent bias and the feeding phase was terminated. The feeding process was completed at the end of 30 minutes even if the infant did not take all of the food. After feeding, the body weight of the infants was measured with only the diaper on and the test weight was determined. After the procedure, the infant was put in the incubator in a right-side position to facilitate gastric discharge. The infant was followed up for 30 minutes after the end of feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values. The recorded data were classified into pre-feeding, feeding, and post-feeding periods, entered into a computer environment, and averaged. The amount of food taken by the infant during the 30-minute feeding period was recorded, and if the infant was unable to take in the entire amount of food prescribed by the physician, he/she took the remaining amount with an orogastric catheter after the post-feeding measurements were finished.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cup feeding | Experimental | Behavioral: Cup feedingThe infants in the control group were fed with a cup. During feeding, all infants in this group were placed in semi-elevated supine position. The position of the infant was adjusted so that when the milk reached the tongue, the infant would start foraging, dip his/her tongue into the milk by dimpling and slurp the milk with his/her tongue through a negative pressure, swallow as much as he/she wants and leave the rest back to the cup. The stopwatch was activated when the infant began to drink the milk from the cup, and the stopwatch was stopped when the infant no longer slurped the milk, and the feeding process was completed. When the infant was physiologically (HR of 120-160/min, SpO2 ≥90) and behaviourally ready, feeding was resumed and the infant was prevented from getting tired during feeding and actively participated in feeding. Feeding time was limited to 30 minutes in either group, including the infants' resting time. |
| Bottle feeding | Experimental | Behavioral: Bottle feedingThe infants in the experimental group were fed with a bottle. The teat of the feeding bottle was selected to be smaller in size, softer and with a smaller hole than the teat of the term infant and suitable for preterm infants. The same brand and model of bottle and teat were used for each infant. All infants in this group were fed in a semi-elevated side-lying position, as it was more similar to the position in which the infant suckled the mother's breast. The infant's lips were tapped with the bottle teat for stimulating to feed, and when the infant opened his/her mouth and drooped his/her tongue, the teat of the bottle was put into his/her mouth. The time elapsed from when the infant started to suck the bottle until he/she released the bottle from his/her mouth was considered as the feeding phase. |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Having diagnostic criteria for severe bronchopulmonary dysplasia (≥30% O2 requirement and/or positive pressure requirement at the 36th postmenstrual week or at discharge in preterm infants with a gestational age of <32 weeks; ≥30% O2 requirement or positive pressure requirement at the 56th postnatal day or at discharge in preterm infants with a gestational age of ≥32 weeks)
- Having an anomaly such as cleft palate, cleft lip
- Having gastrointestinal, neurological or genetic disease (NEC, IVH, hydrocephalus, asphyxia, Down syndrome, short bowel syndrome, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cup feedingThe preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. The infants' heart rate and oxygen saturation were recorded 30 minutes before feeding, and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. Feeding time was limited to 30 minutes, including the infants' resting time. When the infant was no longer sucking, the stopwatch was stopped, and the feeding phase was terminated. The feeding process was completed at the end of 30 minutes even if the infant did not take all of the food. The infant was followed up for 30 minutes after the end of feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values. | Behavioural | Cup feeding |
| Bottle feedingThe preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. The infants' heart rate and oxygen saturation were recorded 30 minutes before feeding, and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. During the feeding period, heart rate and oxygen saturation were continuously recorded. Feeding time was limited to 30 minutes, including the infants' resting time. When the infant was no longer sucking, the stopwatch was stopped, and the feeding phase was terminated. The infant was followed up for 30 minutes after the end of the feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values. | Behavioural | Bottle feeding |
Primary outcome
Feeding Status
Time frame: maximum 30 minutes
In order to assess the feeding status of the infant, his/her time of feeding and the amount of nutrient he/she receives in a minute will be calculated. In order to determine his/her time of feeding, a phone chronometer will be started as soon as he/she begins feeding and it will be stopped when feeding is over. All infants in experimantal group and control group will be fed with a slow-flow bottle branded Avent which is designed for premature infants. It will be calculated how much (cc) of the total amount of nutrient ordered by the doctor the infant receives. The total amount of nutrient received by the infant will be divided into the time of feeding and thus the amount of nutrient received in a minute (cc) will be calculated.
2 secondary outcomes
Heart Rate
Time frame: All babies in experimental group and control group will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 30 minutes before the feeding time, during the feeding and at 30 minutes after the feeding.
Oxygen Saturation
Time frame: All babies in experimental group and control group will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 30 minutes before the feeding time, during the feeding and at 30 minutes after the feeding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu Gözen principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cup feeding and Bottle feeding in people with Oxygen Saturation and Heart Rate, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding Status (time frame: maximum 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.