Testing Four Feeding Approaches to Oral Feeding in Preterm Infants

NCT02024828 | Completed DMC

• 1 other identifier: R01NR005182
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant

Keywords

Infant feeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical outcomes

  Participants will be followed for the duration of the hospital stay, an expected average from starting oral feedings of 3 weeks

• Post-discharge feeding

  2 weeks after discharge

Study Arms (4)

Early/Slow

EXPERIMENTAL

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

Early/Fast

EXPERIMENTAL

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

Late/Slow

EXPERIMENTAL

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

Late/Fast

EXPERIMENTAL

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

Interventions

Early/Slow OTHER

Early/Slow

Early/Fast OTHER

Early/Fast

Late/Slow OTHER

Late/Slow

Late/Fast OTHER

Late/Fast

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

CCHMC

Cincinnati, Ohio, 45229, United States

Location

Related Publications (4)

• 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.

  PMID: 23028391 BACKGROUND

• 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.

  PMID: 21045616 BACKGROUND

• 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.

  PMID: 23185127 RESULT

• 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.

  PMID: 25552910 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 31, 2013
• Study Start: July 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2012
• Last Updated: December 31, 2013

Record last verified: 2011-05

Locations

US (1)