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Clinical Trials/NCT02027688
NCT02027688
Completed
Not Applicable

Feeding Progression in Preterm Infants

University of Pennsylvania2 sites in 1 country55 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Premature, Diseases
Sponsor
University of Pennsylvania
Enrollment
55
Locations
2
Primary Endpoint
Time to full oral feeds
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.

Detailed Description

Preterm infants are at high risk for feeding issues. Feeding difficulties lead to prolonged hospitalization, increase medical complications and raise parental anxiety. The transition from tube feeding to oral feeding is an especially important step in a preterm infant's early life. Currently, there is limited evidence to guide this transition. There are two commonly used schedules for transitioning preterm infants to oral feeding: an every 6 hour schedule and an every 3 hour schedule. However, there is currently no evidence to guide providers in their choice of oral feeding schedule. 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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara DeMauro

MD, MSCE

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • Gestational age between 23 0/7-33 0/7 weeks
  • Eligible for oral (PO) feeding as determined by the attending Neonatologist

Exclusion Criteria

  • Infants with major congenital malformations
  • Infants with chromosomal defects
  • Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
  • Grade 3 or 4 Intraventricular Hemorrhage

Outcomes

Primary Outcomes

Time to full oral feeds

Time Frame: 38 weeks gestation on average

Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.

Secondary Outcomes

  • Time to discharge(40 weeks gestation on average)
  • Medical Complications(38 weeks gestation on average)
  • Growth(40 weeks gestation on average)
  • Feeding skills(40 weeks gestation on average)

Study Sites (2)

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