Feeding, BottleNCT04942106
Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position
A study testing Arm 1 - Side-lying position followed by Supine position and Arm 2 - Supine position followed by Side-lying position in people with Feeding, Bottle and Infant, Premature, Diseases, run by Boston College at 1 site in United States.
Trial summary
The objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Feeding, Bottle, Infant, Premature, Diseases, Behavior, Infant
- What is being tested?
- Arm 1 - Side-lying position followed by Supine position and Arm 2 - Supine position followed by Side-lying position
- 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 siteUnited States
- Study dates
- 10 Mar 2022to 31 May 2024
- 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 Up to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants who are born at ≤ 35 weeks of GA
Who cannot join
- Congenital anomaly that may interfere with feeding (e.g., cleft palate or tracheoesophageal fistula)
- Grade IV intraventricular hemorrhage
- Ventilator-dependence beyond 60 days of life
- Inability to orally feed prior to discharge
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position for Feeding Preterm Infants
The objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. As an exploratory aim, the investigators will also identify potential infant characteristics associated with the intervention response by evaluating infant sex, maturity level, and/or comorbidity. The two bottle-feeding positions will be the semi-elevated side-lying position (hereafter referred to as side-lying position) and the semi-elevated supine position (hereafter referred to as supine position), which is the traditional feeding position when preterm infants are bottle-fed. The investigators hypothesize that compared to the supine position, the side-lying position will be associated with greater physiologic stability in heart rate, respiratory rate, oxygen saturation, and/or autonomic nervous system regulation during and after feeding. The investigators also hypothesize that compared to the supine position, the side-lying position will be associated with more mature patterns of suck-breathe coordination and/or greater feeding skills.
- Being tested
- Arm 1 - Side-lying position followed by Supine position, Arm 2 - Supine position followed by Side-lying position
- Medical subject headings
- Bottle Feeding, Infant, Premature, Diseases, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 - Side-lying position followed by Supine positionOther
Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.
Arm 2 - Supine position followed by Side-lying positionOther
Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.
| Study group | Role | What they receive |
|---|---|---|
| Side-lying position followed by Supine position | Other | In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position. Receives: Other: Arm 1 - Side-lying position followed by Supine position |
| Supine position followed by Side-lying position | Other | In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position. Receives: Other: Arm 2 - Supine position followed by Side-lying position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant physiologic responses to the feeding position - Heart rate (HR)
HR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Measured: Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Respiratory rate (RR)
RR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Measured: Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)
SaO2 will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Measured: Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Heart rate variability (HRV)
HRV will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Measured: Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)
SCOR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Measured: Up to 30 minutes post-feeding
Infant behavioral responses to the feeding position - Suck-breathe coordination
Infant behavioral responses will be assessed by the behavioral observation of suck-breathe coordination patterns using Suck-Breath Coordination coding scheme.
Measured: 5-30 minutes post-baseline
Infant behavioral responses to the feeding position - Infant feeding skill
Infant behavioral responses will be assessed by the behavioral observation of infant feeding skill using the Early Feeding Skills (EFS) assessment tool.
Measured: 5-30 minutes post-baseline
Secondary outcomes (5)
Infant characteristics associated with the intervention response - Infant's sex
Infant's sex (female vs. male)
Measured: At enrollment
Infant characteristics associated with the intervention response - Maturity level
Maturity level will be assessed by gestational age at birth
Measured: At enrollment
Infant characteristics associated with the intervention response - Maturity level
Maturity level will be assessed by postmenstrual age at the time of study
Measured: At the end of the feeding observation, up to 30 minutes post-feeding
Infant characteristics associated with the intervention response - Overall severity of illness
Overall severity illness score will be calculated using the Neonatal Medical Index (range of 1 [least severe] to 5 [most severe])
Measured: At discharge, up to 150 days
Infant characteristics associated with the intervention response - Severity of lung disease
Severity of lung disease will be assessed using diagnostic criteria of bronchopulmonary dysplasia (none, mild, moderate, or severe)
Measured: At discharge, up to 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start10 Mar 2022
- Primary completion31 May 2024
- Study completion31 May 2024
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 Feeding, BottleStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinhee Park, PhD, RN, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942106
- Sponsor's protocol ID
- R21NR019874
- Status last verified
- Jul 2024
- First submitted
- 30 May 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A database will be established to store project data. This data will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. Presentations, abstracts, and manuscripts related to the work will also be centrally stored. Once the project is finished and all analyses are complete, it is our intention to make the study dataset available upon request.
Publications
Park J, Thoyre S, Smallcomb J, Mcternan M, Kneeland T. Biobehavioral Efficacy of the Elevated Side-Lying Position for Feeding Preterm Infants: Study Protocol. J Adv Nurs. 2025 May;81(5):2819-2827. doi: 10.1111/jan.16444. Epub 2024 Sep 4.
PubMed 39231735
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position for Feeding Preterm Infants
- ClinicalTrials.gov ID
- NCT04942106
- Acronym / sponsor ID
- R21NR019874
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, University of North Carolina, Chapel Hill
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 28 Jun 2021 (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 objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. As an exploratory aim, the investigators will also identify potential infant characteristics associated with the intervention response by evaluating infant sex, maturity level, and/or comorbidity. The two bottle-feeding positions will be the semi-elevated side-lying position (hereafter referred to as side-lying position) and the semi-elevated supine position (hereafter referred to as supine position), which is the traditional feeding position when preterm infants are bottle-fed. The investigators hypothesize that compared to the supine position, the side-lying position will be associated with greater physiologic stability in heart rate, respiratory rate, oxygen saturation, and/or autonomic nervous system regulation during and after feeding. The investigators also hypothesize that compared to the supine position, the side-lying position will be associated with more mature patterns of suck-breathe coordination and/or greater feeding skills.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side-lying position followed by Supine position | Other | Other: Arm 1 - Side-lying position followed by Supine positionIn this arm, infants will be bottle-fed in the side-lying position first followed by the supine position. |
| Supine position followed by Side-lying position | Other | Other: Arm 2 - Supine position followed by Side-lying positionIn this arm, infants will be bottle-fed in the supine position first followed by the side-lying position. |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants who are born at ≤ 35 weeks of GA
Key exclusion criteria (4 listed)
- Congenital anomaly that may interfere with feeding (e.g., cleft palate or tracheoesophageal fistula)
- Grade IV intraventricular hemorrhage
- Ventilator-dependence beyond 60 days of life
- Inability to orally feed prior to discharge
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 |
|---|---|---|
| Arm 1 - Side-lying position followed by Supine positionInfants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move. | Other | Side-lying position followed by Supine position |
| Arm 2 - Supine position followed by Side-lying positionInfants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move. | Other | Supine position followed by Side-lying position |
Primary outcome
Infant physiologic responses to the feeding position - Heart rate (HR)
Time frame: Up to 30 minutes post-feeding
HR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Respiratory rate (RR)
Time frame: Up to 30 minutes post-feeding
RR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)
Time frame: Up to 30 minutes post-feeding
SaO2 will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Heart rate variability (HRV)
Time frame: Up to 30 minutes post-feeding
HRV will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)
Time frame: Up to 30 minutes post-feeding
SCOR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant behavioral responses to the feeding position - Suck-breathe coordination
Time frame: 5-30 minutes post-baseline
Infant behavioral responses will be assessed by the behavioral observation of suck-breathe coordination patterns using Suck-Breath Coordination coding scheme.
Infant behavioral responses to the feeding position - Infant feeding skill
Time frame: 5-30 minutes post-baseline
Infant behavioral responses will be assessed by the behavioral observation of infant feeding skill using the Early Feeding Skills (EFS) assessment tool.
5 secondary outcomes
Infant characteristics associated with the intervention response - Infant's sex
Time frame: At enrollment
Infant characteristics associated with the intervention response - Maturity level
Time frame: At enrollment
Infant characteristics associated with the intervention response - Maturity level
Time frame: At the end of the feeding observation, up to 30 minutes post-feeding
Infant characteristics associated with the intervention response - Overall severity of illness
Time frame: At discharge, up to 150 days
Infant characteristics associated with the intervention response - Severity of lung disease
Time frame: At discharge, up to 150 days
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 12 Jul 2024.
- Derived from this study: PubMed 39231735Park J, Thoyre S, Smallcomb J, Mcternan M, Kneeland T. Biobehavioral Efficacy of the Elevated Side-Lying Position for Feeding Preterm Infants: Study Protocol. J Adv Nurs. 2025 May;81(5):2819-2827. doi: 10.1111/jan.16444. Epub 2024 Sep 4.
- Individual participant dataSharing planned: Yes. A database will be established to store project data. This data will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. Presentations, abstracts, and manuscripts related to the work will also be centrally stored. Once the project is finished and all analyses are complete, it is our intention to make the study dataset available upon request.
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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.
Jinhee Park, PhD, RN principal investigator
Boston College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 - Side-lying position followed by Supine position and Arm 2 - Supine position followed by Side-lying position in people with Feeding, Bottle and Infant, Premature, Diseases, run by Boston College at 1 site in United States.
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 4 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 12 Jul 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 United States. 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?
Infant physiologic responses to the feeding position - Heart rate (HR) (time frame: Up to 30 minutes post-feeding). The study lists 7 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 NCT04942106, 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 12 Jul 2024.