Feeding Progression in Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases; Feeding Behavior; Feeding Patterns
• Intervention / Treatment: Other: q6 hour oral feeding schedule; Other: q3 hour oral feeding schedule

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Other: q6 hour oral feeding schedule; The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.
ACTIVE_COMPARATOR: 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.	Other: q3 hour oral feeding schedule; The intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to full oral feeds	Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.	38 weeks gestation on average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge	Assess the relationship between feeding schedule and overall length of hospitalization.	40 weeks gestation on average
Medical Complications	Explore the relationship between feeding schedule and medical complications including apnea of prematurity, bronchopulmonary dysplasia, episodes of suspected sepsis, feeding intolerance and physiologic instability during the time of oral feeds.	38 weeks gestation on average
Growth	Assess the growth during the period of time from initiation of oral feeds to reaching complete oral feeds.	40 weeks gestation on average
Feeding skills	Assess feeding competence and sucking skills from initiation of feeds through discharge on full oral feeds.	40 weeks gestation on average

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Sara B DeMauro, MD, MSCE, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (ESTIMATE): January 6, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Infants; Premature; Neonatal Intensive Care Unit; Oral feeding
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases
• Other Study ID Numbers: 819247