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Feeding Positions for Premature Infants

N/A

Recruiting

Led By Jinhee Park, PhD, RN

Research Sponsored by Boston College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Preterm infants who are born at ≤ 35 weeks of GA

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-30 minutes post-baseline

Awards & highlights

Study Summary

This trial will compare the two most common bottle-feeding positions for preterm infants - side-lying and supine - to see which is more effective.

Who is the study for?

This trial is for preterm infants born at or before 35 weeks of gestational age who can feed orally before discharge. It excludes those with severe brain hemorrhage, congenital anomalies affecting feeding, or those needing a ventilator beyond 60 days.Check my eligibility

What is being tested?

The study compares two bottle-feeding positions in premature babies: side-lying and supine (on their back). Each baby will try both positions to see which one leads to better heart rate, breathing, oxygen levels, nervous system regulation during/after feeding.See study design

What are the potential side effects?

Since this trial involves feeding positions rather than medication, traditional side effects are not expected. However, there may be differences in physiological responses like changes in heart rate or breathing patterns between the positions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby was born at or before 35 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Infant behavioral responses to the feeding position - Infant feeding skill

Infant behavioral responses to the feeding position - Suck-breathe coordination

Infant physiologic responses to the feeding position - Heart rate (HR)

+4 more

Secondary outcome measures

Infant characteristics associated with the intervention response - Infant's sex

Infant characteristics associated with the intervention response - Maturity level

Infant characteristics associated with the intervention response - Overall severity of illness

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Supine position followed by Side-lying positionExperimental Treatment1 Intervention

In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position.

Group II: Side-lying position followed by Supine positionExperimental Treatment1 Intervention

In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston CollegeLead Sponsor

37 Previous Clinical Trials

47,259 Total Patients Enrolled

Beth Israel Deaconess Medical CenterOTHER

837 Previous Clinical Trials

13,010,212 Total Patients Enrolled

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,190,982 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit to participant capacity for this clinical experiment?

"Affirmative. Clinicaltrials.gov's information affirms that this clinical trial is presently recruiting participants, having been published on March 10th 2022 and revised most recently on April 5th 2022. The study requires 60 people to be recruited from one medical center."

Answered by AI

Are there any remaining vacancies for participants in this clinical trial?

"As detailed on clinicaltrials.gov, this medical experiment is actively enlisting participants, with the first posting dating back to March 10th 2022 and most recent update occurring on April 5th of that same year."

Answered by AI

What are the fundamental aims of this medical experiment?

"The purpose of this clinical trial, to be conducted over a 30-minute period post-feeding, is to evaluate infants' respiratory rate responses. Additional secondary outcomes include overall severity of illness score using the Neonatal Medical Index (ranging from 1 [least severe] to 5 [most severe]), infant's sex (female vs male), and degree of bronchopulmonary dysplasia (none, mild, moderate or severe)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

2022. "Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04942106.