Testing Four Feeding Approaches to Oral Feeding in Preterm Infants (PRO)

Feeding Readiness in Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infant
• Intervention / Treatment: Other: Early/Slow; Other: Early/Fast; Other: Late/Slow; Other: Late/Fast

Detailed Description

The study is completed.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • CCHMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Early/Slow
EXPERIMENTAL: 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.	Other: Early/Fast
EXPERIMENTAL: 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.	Other: Late/Slow
EXPERIMENTAL: 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.	Other: Late/Fast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding Performance	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)	One oral feeding a day for 14 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Virginia Commonwealth University

Publications and helpful links

General Publications

• Alberts JR, Pickler RH. Evolution and development of dual ingestion systems in mammals: notes on a new thesis and its clinical implications. Int J Pediatr. 2012;2012:730673. doi: 10.1155/2012/730673. Epub 2012 Sep 18.
• Pickler RH, McGrath JM, Reyna BA, McCain N, Lewis M, Cone S, Wetzel P, Best A. A model of neurodevelopmental risk and protection for preterm infants. J Perinat Neonatal Nurs. 2010 Oct-Dec;24(4):356-65. doi: 10.1097/JPN.0b013e3181fb1e70.
• Pickler RH, Reyna BA, Griffin JB, Lewis M, Thompson AM. Changes in Oral Feeding in Preterm Infants Two Weeks After Hospital Discharge. Newborn Infant Nurs Rev. 2012 Dec 1;12(4):202-206. doi: 10.1053/j.nainr.2012.09.012. Epub 2012 Nov 15.
• Pickler RH, McGrath JM, Reyna BA, Tubbs-Cooley HL, Best AM, Lewis M, Cone S, Wetzel PA. Effects of the neonatal intensive care unit environment on preterm infant oral feeding. Res Rep Neonatol. 2013 Apr 3;2013(3):15-20. doi: 10.2147/RRN.S41280.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 26, 2013
• First Posted (ESTIMATE): December 31, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 31, 2013
• Last Update Submitted That Met QC Criteria: December 26, 2013
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Infant feeding
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: R01NR005182 (NIH)