Feeding Progression in Preterm Infants

Feeding Behavior Clinical Trial

Official title:

Feeding Progression in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027688
• Other study ID #: 819247
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: December 1, 2015
• Start date: July 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Feeding Behavior
• Feeding Patterns
• Infant, Premature, Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to discharge	Assess the relationship between feeding schedule and overall length of hospitalization.	40 weeks gestation on average	No
Secondary	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	Yes
Secondary	Growth	Assess the growth during the period of time from initiation of oral feeds to reaching complete oral feeds.	40 weeks gestation on average	Yes
Secondary	Feeding skills	Assess feeding competence and sucking skills from initiation of feeds through discharge on full oral feeds.	40 weeks gestation on average	No