Testing Four Feeding Approaches to Oral Feeding in Preterm Infants

Preterm Infant Clinical Trial

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Official title:

Feeding Readiness in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024828
• Other study ID #: R01NR005182
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: December 26, 2013
• Start date: July 2006
• Est. completion date: April 2012

Study information

• Verified date: May 2011
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

The study is completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: April 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 32 Weeks

Eligibility

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

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Other:
• Early/Slow

• Early/Fast

• Late/Slow

• Late/Fast

Locations

Country	Name	City	State
United States	CCHMC	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2012 Nov 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No