Bottle FeedingNCT06563973
The Effect of Breast Milk Odor on Feeeding in Preterm Infants
A study testing Milk odor and Pacifier in people with Bottle Feeding and Preterm İnfant, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled experiment to assess the impact of breast milk odor, applied before the first oral feeding of preterm infants transitioning to oral feeding, on their feeding performance. Read more about this study
- Who is it for?
- Ages 26 to 30 weeksHealthy volunteers can take part
- Conditions the study is for
- Bottle Feeding, Preterm İnfant
- What is being tested?
- Milk odor and Pacifier
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2023to 24 Nov 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 26 to 30 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parents must give voluntary consent to participate; the infant must have been born between 26 and 34 weeks of gestation, as determined by the mother's last menstrual period; at the time of the study, the infant must be more than 30 weeks postmenstrual; the infant must be transitioning from enteral to oral feeding for the first time; the infant must be free of health issues other than prematurity; the infant must be fed with the mother's milk; the physician must have approved the infant's readiness for oral feeding; the infant must exhibit physiological and behavioral signs that indicate readiness for oral feeding.
Who cannot join
- severe bronchopulmonary dysplasia; any gastrointestinal, neurological, or genetic disorder (such as necrotizing enterocolitis, intracranial hemorrhage, hydrocephalus, omphalocele, Down syndrome, gastroschisis); any condition that could interfere with oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial anomaly).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breast Milk Odor Applied Before First Oral Feeding on Feeding Performance in Preterm Infants
This study was conducted as a randomized controlled experiment to assess the impact of breast milk odor, applied before the first oral feeding of preterm infants transitioning to oral feeding, on their feeding performance. Infants in the neonatal intensive care unit who were beginning oral feeding were randomly assigned to one of two groups through computer randomization. In the "pacifier" group, infants were given a pacifier for 3 minutes one hour before feeding and again for 2 minutes 10 minutes before feeding to support oral feeding. In contrast, the "breast milk odor and pacifier" group received 2 cc of breast milk, which was dripped onto a sterile sponge and placed about 3 cm from the infant's nose one hour before feeding. At feeding time, all infants in both groups were bottle-fed by the researcher. This marked their first experience with oral feeding. The infants' feeding skills and performance were then evaluated using the Early Feeding Skills (EFS) form during the feeding session.
Read the detailed description
Detailed Description:
Recent research has indicated that olfactory stimulation can serve as an effective nonpharmacological method for enhancing feeding outcomes. Using breast milk for olfactory stimulation is both a cost-efficient and noninvasive approach that may speed up the process of oral feeding and lead to better feeding results. This study aimed to assess the impact of breast milk odor, applied before the first oral feeding of preterm infants transitioning to oral feeding, on their feeding performance. The sample size was calculated using power analysis, based on data from similar studies. As per the analysis, the study intended to include a total of 50 preterm infants, with at least 25 infants in each group. Following verbal and written consent from the families of eligible infants, the study proceeded with those mothers and infants who agreed to participate.
Before Feeding A pulse oximeter was attached to the feet of all infants to monitor their heart rate and oxygen saturation levels. The researcher filled out the "Preterm Infant Identification Form." Nurses caring for the infants included in the study were briefed, and care was provided for 60 minutes before feeding and 10 minutes after feeding to ensure the babies could rest. No painful or stressful procedures were conducted during this period. All interventions were carried out by the researcher in a quiet and calm environment within the incubator to minimize the impact of external factors. Sixty minutes before feeding, all infants were positioned in a semi-elevated side-lying position.
Pacifier Group: To support oral feeding, a pacifier was provided for 3 minutes one hour before feeding time and again for 2 minutes 10 minutes before feeding. Heart rate and oxygen saturation levels were recorded 10 minutes before feeding.
Breast Milk Scent and Pacifier Group: Similar to the pacifier group, infants in this group received a pacifier for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding. Additionally, 2 cc of breast milk was dripped onto a sterile sponge and placed inside the incubator, approximately 3 cm from the infant's nose. Heart rate and oxygen saturation levels were also recorded 10 minutes before feeding.
During Feeding:
Once all pre-feeding procedures were completed and documented, the infant's position remained unchanged by the researcher. The bottle was introduced near the infant's mouth while they were in a semi-raised, side-lying position. The stopwatch was activated as soon as the infant began sucking. To avoid tiring the infant, feeding was limited to 30 minutes. Throughout this period, heart rate (HR) and oxygen saturation (SpO2) were continuously monitored. The infant's feeding skills were assessed using the Early Feeding Skills (EFS) form by an observer nurse who was not involved in the study.
A slow-flow, soft nipple bottle with a smaller hole was used for feeding. To encourage feeding, the researcher gently touched the infant's lips with the bottle nipple. Once the infant's mouth opened, the nipple was placed inside, carefully lowering the tongue. During feeding, any stimulating actions, such as moving or rotating the bottle in the mouth, were avoided.
The infants were closely monitored for signs of fatigue (e.g., reduced sucking, milk leakage, difficulty maintaining posture) and symptoms of physiological or behavioral stress (e.g., pulling the head back, trying to turn away, coughing, grimacing, aspiration, desaturation, apnea, bradycardia, tachycardia). If any stress or fatigue signs were observed, feeding was paused to allow the infant to rest. Feeding resumed once the infant was physiologically stable (HR 120-160/min, SpO2 ≥90) and behaviorally ready.
After Feeding:
To avoid influencing physiological measurements, no interventions were made for 10 minutes post-feeding. The infant's HR, SpO2 values, feeding duration, and the amount of milk consumed during feeding were recorded on the data form.
- Conditions
- Bottle Feeding, Preterm İnfant
- Being tested
- Milk odor, Pacifier
- Keywords
- Feeding Performance, Preterm Infants, Milk Odor
- Medical subject headings
- Bottle Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk odorOther
One hour before feeding time, 2 cc of breast milk was dripped onto a sterile sponge and placed inside the baby's incubator, close to the baby's nose (3 cm).
PacifierOther
To support oral feeding, a pacifier was given for 3 minutes one hour before feeding time and for 2 minutes 10 minutes before feeding time.
| Study group | Role | What they receive |
|---|---|---|
| Breast milk odor and pacifier group | Experimental | A pacifier was given for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding to support oral feeding. In contrast to the control group, 2 cc of breast milk was dripped onto a sterile sponge one hour before feeding and placed in the baby's incubator, close to the nose (3 cm away). Heart rate and oxygen saturation levels were recorded 10 minutes before feeding. Receives: Other: Milk odor; Other: Pacifier |
| Pacifier group | Active comparator | A pacifier was provided for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding to support oral feeding. Heart rate and oxygen saturation levels were recorded 10 minutes prior to feeding. Receives: Other: Pacifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Feeding Skills
An observer nurse, who was not part of the research team, evaluated the infant's feeding skills using the Early Feeding Skills (EFS) Evaluation Form.
Measured: during feeding up to 1 hour
The feeding duration (Feeding performance)
The infant's feeding performance was assessed by calculating the feeding duration. To measure feeding time, a stopwatch on a phone was activated at the start of feeding and stopped once feeding concluded.
Measured: immediately after feeding
Feeding performance
The infant's feeding performance was assessed by calculating the amount of food consumed per minute. The total amount of food the infant consumed (in cc) was then compared to the amount prescribed by the doctor.
Measured: immediately after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start18 Apr 2023
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bottle FeedingStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Genç, Istanbul University - Cerrahpasa
- Investigators
- Duygu Gözen, Prof., Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563973
- Sponsor's protocol ID
- 2022/0715
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Genc C, Musaoglu S, Gozen D, Ovali F. Impact of breast milk odor exposure on first oral feeding performance in preterm infants following non-nutritive sucking. J Perinatol. 2026 Jul 27. doi: 10.1038/s41372-026-02836-1. Online ahead of print.
PubMed 42509306
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Milk Odor Applied Before First Oral Feeding on Feeding Performance in Preterm Infants
- ClinicalTrials.gov ID
- NCT06563973
- Acronym / sponsor ID
- 2022/0715
- Conditions
- Bottle Feeding, Preterm İnfant
- Keywords
- Feeding Performance, Preterm Infants, Milk Odor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 21 Aug 2024 (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.
This study was conducted as a randomized controlled experiment to assess the impact of breast milk odor, applied before the first oral feeding of preterm infants transitioning to oral feeding, on their feeding performance. Infants in the neonatal intensive care unit who were beginning oral feeding were randomly assigned to one of two groups through computer randomization. In the "pacifier" group, infants were given a pacifier for 3 minutes one hour before feeding and again for 2 minutes 10 minutes before feeding to support oral feeding. In contrast, the "breast milk odor and pacifier" group received 2 cc of breast milk, which was dripped onto a sterile sponge and placed about 3 cm from the infant's nose one hour before feeding. At feeding time, all infants in both groups were bottle-fed by the researcher. This marked their first experience with oral feeding. The infants' feeding skills and performance were then evaluated using the Early Feeding Skills (EFS) form during the feeding session.
Detailed description
Detailed Description:
Recent research has indicated that olfactory stimulation can serve as an effective nonpharmacological method for enhancing feeding outcomes. Using breast milk for olfactory stimulation is both a cost-efficient and noninvasive approach that may speed up the process of oral feeding and lead to better feeding results. This study aimed to assess the impact of breast milk odor, applied before the first oral feeding of preterm infants transitioning to oral feeding, on their feeding performance. The sample size was calculated using power analysis, based on data from similar studies. As per the analysis, the study intended to include a total of 50 preterm infants, with at least 25 infants in each group. Following verbal and written consent from the families of eligible infants, the study proceeded with those mothers and infants who agreed to participate.
Before Feeding A pulse oximeter was attached to the feet of all infants to monitor their heart rate and oxygen saturation levels. The researcher filled out the "Preterm Infant Identification Form." Nurses caring for the infants included in the study were briefed, and care was provided for 60 minutes before feeding and 10 minutes after feeding to ensure the babies could rest. No painful or stressful procedures were conducted during this period. All interventions were carried out by the researcher in a quiet and calm environment within the incubator to minimize the impact of external factors. Sixty minutes before feeding, all infants were positioned in a semi-elevated side-lying position.
Pacifier Group: To support oral feeding, a pacifier was provided for 3 minutes one hour before feeding time and again for 2 minutes 10 minutes before feeding. Heart rate and oxygen saturation levels were recorded 10 minutes before feeding.
Breast Milk Scent and Pacifier Group: Similar to the pacifier group, infants in this group received a pacifier for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding. Additionally, 2 cc of breast milk was dripped onto a sterile sponge and placed inside the incubator, approximately 3 cm from the infant's nose. Heart rate and oxygen saturation levels were also recorded 10 minutes before feeding.
During Feeding:
Once all pre-feeding procedures were completed and documented, the infant's position remained unchanged by the researcher. The bottle was introduced near the infant's mouth while they were in a semi-raised, side-lying position. The stopwatch was activated as soon as the infant began sucking. To avoid tiring the infant, feeding was limited to 30 minutes. Throughout this period, heart rate (HR) and oxygen saturation (SpO2) were continuously monitored. The infant's feeding skills were assessed using the Early Feeding Skills (EFS) form by an observer nurse who was not involved in the study.
A slow-flow, soft nipple bottle with a smaller hole was used for feeding. To encourage feeding, the researcher gently touched the infant's lips with the bottle nipple. Once the infant's mouth opened, the nipple was placed inside, carefully lowering the tongue. During feeding, any stimulating actions, such as moving or rotating the bottle in the mouth, were avoided.
The infants were closely monitored for signs of fatigue (e.g., reduced sucking, milk leakage, difficulty maintaining posture) and symptoms of physiological or behavioral stress (e.g., pulling the head back, trying to turn away, coughing, grimacing, aspiration, desaturation, apnea, bradycardia, tachycardia). If any stress or fatigue signs were observed, feeding was paused to allow the infant to rest. Feeding resumed once the infant was physiologically stable (HR 120-160/min, SpO2 ≥90) and behaviorally ready.
After Feeding:
To avoid influencing physiological measurements, no interventions were made for 10 minutes post-feeding. The infant's HR, SpO2 values, feeding duration, and the amount of milk consumed during feeding were recorded on the data form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast milk odor and pacifier group | Experimental | Other: Milk odor, Other: PacifierA pacifier was given for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding to support oral feeding. In contrast to the control group, 2 cc of breast milk was dripped onto a sterile sponge one hour before feeding and placed in the baby's incubator, close to the nose (3 cm away). Heart rate and oxygen saturation levels were recorded 10 minutes before feeding. |
| Pacifier group | Active comparator | Other: PacifierA pacifier was provided for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding to support oral feeding. Heart rate and oxygen saturation levels were recorded 10 minutes prior to feeding. |
Who may qualify
- Ages
- 26 to 30 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- parents must give voluntary consent to participate; the infant must have been born between 26 and 34 weeks of gestation, as determined by the mother's last menstrual period; at the time of the study, the infant must be more than 30 weeks postmenstrual; the infant must be transitioning from enteral to oral feeding for the first time; the infant must be free of health issues other than prematurity; the infant must be fed with the mother's milk; the physician must have approved the infant's readiness for oral feeding; the infant must exhibit physiological and behavioral signs that indicate readiness for oral feeding.
Key exclusion criteria (1 listed)
- severe bronchopulmonary dysplasia; any gastrointestinal, neurological, or genetic disorder (such as necrotizing enterocolitis, intracranial hemorrhage, hydrocephalus, omphalocele, Down syndrome, gastroschisis); any condition that could interfere with oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial anomaly).
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 |
|---|---|---|
| Milk odorOne hour before feeding time, 2 cc of breast milk was dripped onto a sterile sponge and placed inside the baby's incubator, close to the baby's nose (3 cm). | Other | Breast milk odor and pacifier group |
| PacifierTo support oral feeding, a pacifier was given for 3 minutes one hour before feeding time and for 2 minutes 10 minutes before feeding time. | Other | Breast milk odor and pacifier group, Pacifier group |
Primary outcome
Early Feeding Skills
Time frame: during feeding up to 1 hour
An observer nurse, who was not part of the research team, evaluated the infant's feeding skills using the Early Feeding Skills (EFS) Evaluation Form.
The feeding duration (Feeding performance)
Time frame: immediately after feeding
The infant's feeding performance was assessed by calculating the feeding duration. To measure feeding time, a stopwatch on a phone was activated at the start of feeding and stopped once feeding concluded.
Feeding performance
Time frame: immediately after feeding
The infant's feeding performance was assessed by calculating the amount of food consumed per minute. The total amount of food the infant consumed (in cc) was then compared to the amount prescribed by the doctor.
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 23 Aug 2024.
- Derived from this study: PubMed 42509306Genc C, Musaoglu S, Gozen D, Ovali F. Impact of breast milk odor exposure on first oral feeding performance in preterm infants following non-nutritive sucking. J Perinatol. 2026 Jul 27. doi: 10.1038/s41372-026-02836-1. Online ahead of print.
- Individual participant dataSharing planned: No
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Recruiting
Positive Feeding of the Preterm Infant
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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, Prof. principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk odor and Pacifier in people with Bottle Feeding and Preterm İnfant, 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 1 inclusion and 1 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 23 Aug 2024. 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?
Early Feeding Skills (time frame: during feeding up to 1 hour). The study lists 3 primary outcomes in all. 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 NCT06563973, which also lists 1 linked publication.
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 23 Aug 2024.