PretermNCT05651035
Breastfeeding and Bottle Feeding: Impact on Preterm Infants' Physiology and Feeding Performance
A study testing oral feeding in people with Preterm and Breastfeeding, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effect of breastfeeding on the infant's test weight and physiological characteristics (oxygen saturation and heart rate) in preterm infants in the Neonatal Intensive Care Unit during the transition to oral feeding. Read more about this study
- Who is it for?
- Ages 32 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Breastfeeding, Bottlefeeding
- What is being tested?
- oral feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 31 Dec 2023
- 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 32 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestation week at birth determined according to the mother's last menstrual date is 26-31+6 weeks,
- Postmenstrual week at the time of the study was 32-36+6 weeks,
- Having a body weight of 1500 grams or more at the time of inclusion in the study,
- Suggested by the physician to switch to oral nutrition and switched from enteral nutrition to oral nutrition for the first time,
- Breastfed,
- Preterm infants whose parents' consent was obtained for inclusion in the study and whose parents signed the informed consent form
Who cannot join
- Receiving oxygen,
- Craniofacial anomalies such as cleft palate, cleft lip, facial muscle paralysis,
- Preterm infants with any gastrointestinal, neurological and genetic disease (necrotizing enterocolitis, third and fourth level intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, down syndrome, omphalocele, non-gastrodeia, short bowel syndrome and other diseases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Breastfeeding and Bottle Feeding as the Initial Oral Feeding on Physiological Parameters and Feeding Performance in Preterm Infants: A Randomized Controlled Study
The goal of this clinical trial is to evaluate the effect of breastfeeding on the infant's test weight and physiological characteristics (oxygen saturation and heart rate) in preterm infants in the Neonatal Intensive Care Unit during the transition to oral feeding.
The main question it aims to answer are:
- Is there a difference in test weight and physiological parameters between the infants in whom the first oral feeding was performed by the mother and the infants in whom the first oral feeding was performed by the intensive care unit nurse with a bottle? Researchers will compare the breastfed group with the bottle-fed group to see if there are differences in test weight and physiological parameters.
Read the detailed description
In the pre-feeding stage of the research, the parents of the preterms included in the sample will be met and informed about the research. Written and verbal consent will be obtained from parents who agreed to participate in the study. "Preterm Infants Information Form" will be filled by the researcher before feeding and "Feeding Monitoring Form" will be filled during feeding. By randomization, it will be determined which of the experimental and control groups the preterm infant will be assigned to. It will be ensured that the interventions that will affect the vital signs of the preterms in both groups before feeding are not applied. Oxygen saturation and heart rate will be monitored for 30 minutes before, during and after feeding for all groups. Preterms in both groups will be dressed in clean and dry diapers by cleaning their bottoms before feeding, and will be weighed naked with a digital baby scale by removing their clothes. Weighing the preterms with an electronic precision balance before and after feeding - the test weighing - will be used to measure the amount of milk the preterm is expressing from the breast or bottle. The preterm will then be fed loosely wrapped in a cotton blanket. If the oxygen saturation level of all preterm infants falls below 90% during feeding, it will be considered desaturated and the feeding will be stopped. The preterm infants will continue to be fed when the oxygen saturation is ≥ 90% and the heart rate is 120-160/min. Feeding will be limited to a total of 30 minutes for infants in both groups, including rest intervals, and will not take longer. When the feeding is complete, preterms in both groups will be weighed naked without changing the diaper under the feeding process. It will be ensured that interventions that may affect the vital signs of all preterms included in the study are not applied when feeding is completed. The oxygen saturation and heart rate of the preterms in both groups will be monitored for 30 minutes after the feeding is completed. When feeding is complete, preterms in both groups will be placed on the same mother's breast in the right lateral position to facilitate gastric emptying.
- Conditions
- Preterm, Breastfeeding, Bottlefeeding, Premature
- Being tested
- oral feeding
- Keywords
- preterm infants, oral feeding, breastfeeding, bottlefeeding, physiological parameters, test weighing, initial oral feeding, Neonatal Intensive Care Unit, Cue-Based oral feeding, Transition to oral feeding
- Medical subject headings
- Premature Birth, Breast Feeding, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral feedingOther
In experimental group infants: Preterms in this group will be breastfed by their own mother.
In control group infants: Preterms in this group will be fed by the researcher by putting the baby's own mother's milk in the bottle. During feeding, the preterm will be placed on the lap by the researcher in a standing position on the same mother's breast, and will be given a raised side-lying position. In this position, the preterm's head and body will be elevated 45-60 degrees with the help of a small pillow. While the researcher will support the preterm's head, neck and shoulder with one hand, he will control the bottle with the other hand. By touching the preterm's nipple to the preterm's lips, the preterm will be prepared for feeding, and the bottle will be placed in the baby's mouth with the mouth opening and the tongue lowering. During feeding, stimulating movements such as pushing the bottle back and forth in the mouth, which will lead the newborn to suck faster, will not be made.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding group | Experimental | Preterm infants in this group are breastfed by their mothers during their first oral feeding. Before, during and after feeding, the preterm infant's oxygen saturation level and peak heart rate are measured for 30 minutes. In addition, the test test weighing is determined by weighing the baby before and after feeding. Receives: Other: oral feeding |
| Bottle-feeding group | No intervention | Preterm infants in this group are fed with their mother's milk in the bottle during their first oral feeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
preterm infant's weight gain
It is to determine the weight gain by weighing the preterm infant with the same diaper before and after oral feeding.
Measured: 30 minutes before oral feeding and 30 minutes after oral feeding is complete
Secondary outcomes (2)
Oxygen saturation
Oxygen saturation ≥ 90% during and just after oral feeding
Measured: 30 minutes
Heart rate
Heart rate 120-160/min during and just after oral feeding
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start15 Dec 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PretermStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagihan Sabaz, Istanbul University - Cerrahpasa
- Investigators
- Duygu Gözen, Ph.D., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651035
- Sponsor's protocol ID
- 10840098-604.01.01-E.14287
- Status last verified
- Apr 2025
- First submitted
- 29 Nov 2022
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Girgin BA, Gozen D, Karatekin G. Effects of two different feeding positions on physiological characteristics and feeding performance of preterm infants: A randomized controlled trial. J Spec Pediatr Nurs. 2018 Apr;23(2):e12214. doi: 10.1111/jspn.12214. Epub 2018 Mar 5.
PubMed 29504676Chen CH, Wang TM, Chang HM, Chi CS. The effect of breast- and bottle-feeding on oxygen saturation and body temperature in preterm infants. J Hum Lact. 2000 Feb;16(1):21-7. doi: 10.1177/089033440001600105.
PubMed 11138220Fontana C, Menis C, Pesenti N, Passera S, Liotto N, Mosca F, Roggero P, Fumagalli M. Effects of early intervention on feeding behavior in preterm infants: A randomized controlled trial. Early Hum Dev. 2018 Jun;121:15-20. doi: 10.1016/j.earlhumdev.2018.04.016. Epub 2018 May 3.
PubMed 29730130Goldfield EC, Richardson MJ, Lee KG, Margetts S. Coordination of sucking, swallowing, and breathing and oxygen saturation during early infant breast-feeding and bottle-feeding. Pediatr Res. 2006 Oct;60(4):450-5. doi: 10.1203/01.pdr.0000238378.24238.9d. Epub 2006 Aug 28.
PubMed 16940236Gianni ML, Sannino P, Bezze E, Comito C, Plevani L, Roggero P, Agosti M, Mosca F. Does parental involvement affect the development of feeding skills in preterm infants? A prospective study. Early Hum Dev. 2016 Dec;103:123-128. doi: 10.1016/j.earlhumdev.2016.08.006. Epub 2016 Aug 31.
PubMed 27591506Rocha NM, Martinez FE, Jorge SM. Cup or bottle for preterm infants: effects on oxygen saturation, weight gain, and breastfeeding. J Hum Lact. 2002 May;18(2):132-8. doi: 10.1177/089033440201800204.
PubMed 12033074Moral A, Bolibar I, Seguranyes G, Ustrell JM, Sebastia G, Martinez-Barba C, Rios J. Mechanics of sucking: comparison between bottle feeding and breastfeeding. BMC Pediatr. 2010 Feb 11;10:6. doi: 10.1186/1471-2431-10-6.
PubMed 20149217Stevens EE, Gazza E, Pickler R. Parental experience learning to feed their preterm infants. Adv Neonatal Care. 2014 Oct;14(5):354-61. doi: 10.1097/ANC.0000000000000105.
PubMed 25000100Thoyre SM, Pados BF, Shaker CS, Fuller K, Park J. Psychometric Properties of the Early Feeding Skills Assessment Tool. Adv Neonatal Care. 2018 Oct;18(5):E13-E23. doi: 10.1097/ANC.0000000000000537.
PubMed 30239407Settle M, Francis K. Does the Infant-Driven Feeding Method Positively Impact Preterm Infant Feeding Outcomes? Adv Neonatal Care. 2019 Feb;19(1):51-55. doi: 10.1097/ANC.0000000000000577.
PubMed 30672812Sabaz N, Gozen D, Tastekin A. Effects of breastfeeding and bottle feeding as the initial oral feeding on physiological parameters and feeding performance in preterm infants: A randomized controlled study. J Pediatr Gastroenterol Nutr. 2026 Feb;82(2):592-604. doi: 10.1002/jpn3.70295. Epub 2025 Nov 29.
PubMed 41318959
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breastfeeding and Bottle Feeding as the Initial Oral Feeding on Physiological Parameters and Feeding Performance in Preterm Infants: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05651035
- Acronym / sponsor ID
- 10840098-604.01.01-E.14287
- Conditions
- Preterm, Breastfeeding, Bottlefeeding, Premature
- Keywords
- preterm infants, oral feeding, breastfeeding, bottlefeeding, physiological parameters, test weighing, initial oral feeding, Neonatal Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Dec 2022 (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 goal of this clinical trial is to evaluate the effect of breastfeeding on the infant's test weight and physiological characteristics (oxygen saturation and heart rate) in preterm infants in the Neonatal Intensive Care Unit during the transition to oral feeding.
The main question it aims to answer are:
- Is there a difference in test weight and physiological parameters between the infants in whom the first oral feeding was performed by the mother and the infants in whom the first oral feeding was performed by the intensive care unit nurse with a bottle? Researchers will compare the breastfed group with the bottle-fed group to see if there are differences in test weight and physiological parameters.
Detailed description
In the pre-feeding stage of the research, the parents of the preterms included in the sample will be met and informed about the research. Written and verbal consent will be obtained from parents who agreed to participate in the study. "Preterm Infants Information Form" will be filled by the researcher before feeding and "Feeding Monitoring Form" will be filled during feeding. By randomization, it will be determined which of the experimental and control groups the preterm infant will be assigned to. It will be ensured that the interventions that will affect the vital signs of the preterms in both groups before feeding are not applied. Oxygen saturation and heart rate will be monitored for 30 minutes before, during and after feeding for all groups. Preterms in both groups will be dressed in clean and dry diapers by cleaning their bottoms before feeding, and will be weighed naked with a digital baby scale by removing their clothes. Weighing the preterms with an electronic precision balance before and after feeding - the test weighing - will be used to measure the amount of milk the preterm is expressing from the breast or bottle. The preterm will then be fed loosely wrapped in a cotton blanket. If the oxygen saturation level of all preterm infants falls below 90% during feeding, it will be considered desaturated and the feeding will be stopped. The preterm infants will continue to be fed when the oxygen saturation is ≥ 90% and the heart rate is 120-160/min. Feeding will be limited to a total of 30 minutes for infants in both groups, including rest intervals, and will not take longer. When the feeding is complete, preterms in both groups will be weighed naked without changing the diaper under the feeding process. It will be ensured that interventions that may affect the vital signs of all preterms included in the study are not applied when feeding is completed. The oxygen saturation and heart rate of the preterms in both groups will be monitored for 30 minutes after the feeding is completed. When feeding is complete, preterms in both groups will be placed on the same mother's breast in the right lateral position to facilitate gastric emptying.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding group | Experimental | Other: oral feedingPreterm infants in this group are breastfed by their mothers during their first oral feeding. Before, during and after feeding, the preterm infant's oxygen saturation level and peak heart rate are measured for 30 minutes. In addition, the test test weighing is determined by weighing the baby before and after feeding. |
| Bottle-feeding group | No intervention | –Preterm infants in this group are fed with their mother's milk in the bottle during their first oral feeding. |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestation week at birth determined according to the mother's last menstrual date is 26-31+6 weeks,
- Postmenstrual week at the time of the study was 32-36+6 weeks,
- Having a body weight of 1500 grams or more at the time of inclusion in the study,
- Suggested by the physician to switch to oral nutrition and switched from enteral nutrition to oral nutrition for the first time,
- Breastfed,
Key exclusion criteria (3 listed)
- Receiving oxygen,
- Craniofacial anomalies such as cleft palate, cleft lip, facial muscle paralysis,
- Preterm infants with any gastrointestinal, neurological and genetic disease (necrotizing enterocolitis, third and fourth level intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, down syndrome, omphalocele, non-gastrodeia, short bowel syndrome and other diseases)
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 |
|---|---|---|
| oral feedingIn experimental group infants: Preterms in this group will be breastfed by their own mother. In control group infants: Preterms in this group will be fed by the researcher by putting the baby's own mother's milk in the bottle. During feeding, the preterm will be placed on the lap by the researcher in a standing position on the same mother's breast, and will be given a raised side-lying position. In this position, the preterm's head and body will be elevated 45-60 degrees with the help of a small pillow. While the researcher will support the preterm's head, neck and shoulder with one hand, he will control the bottle with the other hand. By touching the preterm's nipple to the preterm's lips, the preterm will be prepared for feeding, and the bottle will be placed in the baby's mouth with the mouth opening and the tongue lowering. During feeding, stimulating movements such as pushing the bottle back and forth in the mouth, which will lead the newborn to suck faster, will not be made. | Other | Breastfeeding group |
Primary outcome
preterm infant's weight gain
Time frame: 30 minutes before oral feeding and 30 minutes after oral feeding is complete
It is to determine the weight gain by weighing the preterm infant with the same diaper before and after oral feeding.
2 secondary outcomes
Oxygen saturation
Time frame: 30 minutes
Heart rate
Time frame: 30 minutes
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 8 Apr 2025.
- Results publication: PubMed 29504676Girgin BA, Gozen D, Karatekin G. Effects of two different feeding positions on physiological characteristics and feeding performance of preterm infants: A randomized controlled trial. J Spec Pediatr Nurs. 2018 Apr;23(2):e12214. doi: 10.1111/jspn.12214. Epub 2018 Mar 5.
- Results publication: PubMed 11138220Chen CH, Wang TM, Chang HM, Chi CS. The effect of breast- and bottle-feeding on oxygen saturation and body temperature in preterm infants. J Hum Lact. 2000 Feb;16(1):21-7. doi: 10.1177/089033440001600105.
- Results publication: PubMed 29730130Fontana C, Menis C, Pesenti N, Passera S, Liotto N, Mosca F, Roggero P, Fumagalli M. Effects of early intervention on feeding behavior in preterm infants: A randomized controlled trial. Early Hum Dev. 2018 Jun;121:15-20. doi: 10.1016/j.earlhumdev.2018.04.016. Epub 2018 May 3.
- Results publication: PubMed 16940236Goldfield EC, Richardson MJ, Lee KG, Margetts S. Coordination of sucking, swallowing, and breathing and oxygen saturation during early infant breast-feeding and bottle-feeding. Pediatr Res. 2006 Oct;60(4):450-5. doi: 10.1203/01.pdr.0000238378.24238.9d. Epub 2006 Aug 28.
- Results publication: PubMed 27591506Gianni ML, Sannino P, Bezze E, Comito C, Plevani L, Roggero P, Agosti M, Mosca F. Does parental involvement affect the development of feeding skills in preterm infants? A prospective study. Early Hum Dev. 2016 Dec;103:123-128. doi: 10.1016/j.earlhumdev.2016.08.006. Epub 2016 Aug 31.
- Results publication: PubMed 12033074Rocha NM, Martinez FE, Jorge SM. Cup or bottle for preterm infants: effects on oxygen saturation, weight gain, and breastfeeding. J Hum Lact. 2002 May;18(2):132-8. doi: 10.1177/089033440201800204.
- Results publication: PubMed 20149217Moral A, Bolibar I, Seguranyes G, Ustrell JM, Sebastia G, Martinez-Barba C, Rios J. Mechanics of sucking: comparison between bottle feeding and breastfeeding. BMC Pediatr. 2010 Feb 11;10:6. doi: 10.1186/1471-2431-10-6.
- Results publication: PubMed 25000100Stevens EE, Gazza E, Pickler R. Parental experience learning to feed their preterm infants. Adv Neonatal Care. 2014 Oct;14(5):354-61. doi: 10.1097/ANC.0000000000000105.
- Results publication: PubMed 30239407Thoyre SM, Pados BF, Shaker CS, Fuller K, Park J. Psychometric Properties of the Early Feeding Skills Assessment Tool. Adv Neonatal Care. 2018 Oct;18(5):E13-E23. doi: 10.1097/ANC.0000000000000537.
- Results publication: PubMed 30672812Settle M, Francis K. Does the Infant-Driven Feeding Method Positively Impact Preterm Infant Feeding Outcomes? Adv Neonatal Care. 2019 Feb;19(1):51-55. doi: 10.1097/ANC.0000000000000577.
- Derived from this study: PubMed 41318959Sabaz N, Gozen D, Tastekin A. Effects of breastfeeding and bottle feeding as the initial oral feeding on physiological parameters and feeding performance in preterm infants: A randomized controlled study. J Pediatr Gastroenterol Nutr. 2026 Feb;82(2):592-604. doi: 10.1002/jpn3.70295. Epub 2025 Nov 29.
- Assessment of Oral Feeding Readiness in Preterm InfantsLink provided by the sponsor.
- Evidence-Based Interventions Supporting Oral Feeding in Preterm InfantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, Ph.D. study director
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 oral feeding in people with Preterm and Breastfeeding, 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 6 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 8 Apr 2025. 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?
preterm infant's weight gain (time frame: 30 minutes before oral feeding and 30 minutes after oral feeding is complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05651035, which also lists 11 linked publications.
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 8 Apr 2025.