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Feeding Positions for Premature Infants
Boston, MA
N/A
Waitlist Available
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
Must not have
Grade IV intraventricular hemorrhage
Ventilator-dependence beyond 60 days of life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-30 minutes post-baseline
Awards & highlights
No Placebo-Only Group
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.
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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 belowSelect...
My baby was born at or before 35 weeks of pregnancy.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a severe brain bleed.
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I have been on a ventilator for more than 60 days.
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Select...
I cannot eat by mouth before leaving the hospital.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Closest Location:Beth Israel Deaconess Medical Center· Boston, MA· 1444 miles
Who is running the clinical trial?
Boston CollegeLead Sponsor
39 Previous Clinical Trials
49,253 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
869 Previous Clinical Trials
12,930,863 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,584 Previous Clinical Trials
4,363,689 Total Patients Enrolled
Jinhee Park, PhD, RNPrincipal InvestigatorBoston College