Testing Four Feeding Approaches to Oral Feeding in Preterm Infants

Not Applicable

Completed

• Conditions: Preterm Infant
• Interventions: Other: Early/Slow; Other: Early/Fast; Other: Late/Slow; Other: Late/Fast

• Registration Number: NCT02024828
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

The purpose of this study was to test the effect of four randomly assigned approaches to oral feeding transition on feeding outcomes in preterm infants.

Detailed Description

The study is completed.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2011-01
• Status Verified: 2011-05
• Study Completion: 2012-04
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-26
• Last Update Submitted: 2013-12-26
• Study First Posted: 2013-12-31
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• 1. the infant's gestational age at birth was less than 32 weeks; 2) the infant was receiving enteral feedings every three hours; 3) the infant was able medically to feed orally by 32 weeks post-menstrual age (PMA); and 3) the parents gave consent for the infant's participation.

Exclusion Criteria

• 1. they were unable to begin oral feeding at 32 weeks PMA due to gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects; 2) had surgical necrotizing enterocolitis; or 3) needed ventilator support, including nasal continuous positive airway pressure (CPAP), beyond 32 weeks PMA. Infants receiving oxygen by cannula were included.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early/Slow	Early/Slow	Infants were offered oral feedings beginning at 32 weeks PMA. They were offered 2 oral feedings per day for 3 days (Days 1-3). The number of oral feedings offered per day increased by 1 feeding every other day until day 14 when they were offered 8 oral feedings each day (Days 4-5, 3 oral feeds offered; Days 6-7, 4 oral feeds offered; Days 8-9, 5 oral feeds offered; Days 10-11, 6 oral feeds offered; Days 12-13, 7 oral feeds offered; Day14, 8 oral feeds offered). Any feedings not offered orally were provided by gavage.
Early/Fast	Early/Fast	Infants were first offered oral feedings beginning at 32 weeks PMA. They were offered 8 oral feedings every day, at each of 8 scheduled daily feedings.
Late/Slow	Late/Slow	Infants were offered oral feedings beginning at 34 weeks PMA. They were offered 2 oral feedings per day for 3 days (Days 1-3). The number of oral feedings offered per day increased by 1 feeding every other day until day 14 when they were offered 8 oral feedings each day (Days 4-5, 3 oral feeds offered; Days 6-7, 4 oral feeds offered; Days 8-9, 5 oral feeds offered; Days 10-11, 6 oral feeds offered; Days 12-13, 7 oral feeds offered; Day14, 8 oral feeds offered). Any feedings not offered orally were provided by gavage.
Late/Fast	Late/Fast	Infants were offered oral feedings beginning at 34 weeks PMA. They were offered 8 oral feedings every day, at each of 8 scheduled daily feedings.

Primary Outcome Measures

Name	Time	Method
Feeding Performance	One oral feeding a day for 14 days	Includes 3 components: Proportion consumed (volume taken/volume ordered), rate of consumption (volume consumed/minutes of feeding); proficiency (volume taken in first 5 minutes of feeding/volume ordered)

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes	Participants will be followed for the duration of the hospital stay, an expected average from starting oral feedings of 3 weeks	Days to discharge from first oral feeding
Post-discharge feeding	2 weeks after discharge	Performance at feeding 2 weeks after hospital discharge using the Early Infant Feeding Scale, an observational tool of infant feeding behaviors

Trial Locations

Locations (1)

CCHMC; 🇺🇸 Cincinnati, Ohio, United States