Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2014-07-31
2015-04-30
Brief Summary
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Detailed Description
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The primary objective of this study is to explore whether an every 6 (q6) hour oral feeding schedule will improve time to full oral feedings as compared to an every 3 (q3) hour oral feeding schedule. The secondary objectives are to test whether every 6 hour feeding allows for improved medical stability and oral-motor coordination as compared to the other commonly used q3 hour schedule. Each infant will be randomly assigned to a q6 hour or q3 hour oral feeding schedule. Data on oral feeding progression, respiratory status and oral motor proficiency will be collected and compared. The study will collect data on how long it takes each infant to get to full oral feeds, respiratory status throughout their time of oral feeding, whether there were any episodes of medical complications, measures of oral motor feeding skills, and the time to discharge from the hospital. This study is a crucial first step towards determining which feeding schedule is optimal for preterm infants to ensure timely attainment of full oral feeds and hospital discharge without compromising medical stability.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Every 6 hour Feeding Schedule
Infants in this arm will be offered oral feedings every 6 hours if they are safe and ready to feed by mouth.
q6 hour oral feeding schedule
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.
Every 3 Hour Oral Feeding
Infants in this arm will be offered oral feedings every 3 hours if they are safe and ready to feed by mouth.
q3 hour oral feeding schedule
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours.
Interventions
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q6 hour oral feeding schedule
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.
q3 hour oral feeding schedule
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours.
Eligibility Criteria
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Inclusion Criteria
* Eligible for oral (PO) feeding as determined by the attending Neonatologist
Exclusion Criteria
* Infants with chromosomal defects
* Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
* Grade 3 or 4 Intraventricular Hemorrhage
120 Days
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Sara DeMauro
MD, MSCE
Principal Investigators
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Sara B DeMauro, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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819247
Identifier Type: -
Identifier Source: org_study_id