NCT02661360

Effects of Swaddling on Infants During Feeding

Effects of Swaddling During Bottle Feeding on Infants Born Preterm

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

Summary

The purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm. Results from research will have implication on neurobehavioral and physiologic outcomes as important indicators for the possible effect of swaddling during bottle feeding.

Detailed description

Once an infant is orally feeding a minimum of two times per nursing shift for four consecutive nursing shifts, the infant will be randomly assigned to receive the intervention (swaddling) or control condition (no swaddling) first, by the research OT randomly choosing an envelope with the assignment enclosed. The intervention and control feedings for each infant will be consecutive and will take place at the infant's bedside in the NICU. Infants will be assessed at each nursing care time for feeding readiness by the research OT and feeding OT according the policies of the NYU Langone Medical Center NICU, which utilizes the Infant-Driven Feeding Scale-Readiness (Appendix B) (Ludwig \& Waitzman, 2006). When the infant demonstrates readiness, the first condition will be initiated. At the next feeding when the infant demonstrates readiness, the opposite condition will be applied. If the infant is not available due to procedures or not demonstrating feeding readiness, at the next two caregiving times after the first feeding, the infant will be discontinued for that day and will start the study over the next day.

Conditions

• Premature Birth

Interventions

Type	Name	Description
BEHAVIORAL	Swaddling Intervention for Preterm Infants	Procedure for swaddling includes folding one corner of the blanket down two thirds of the way down the blanket in order to make the blanket into a triangular shape. The infant will be positioned with shoulders at the fold of the blanket. The infant will be positioned with the blanket so that elbows, hips, and knees flexed with hands near the face by wrapping one side of the blanket across the chest holding the hands in place, pulling the bottom corner up toward the infant's face, and securing the blanket with the last corner pulled across the infant's chest again and around their back. The blanket will be tight enough to keep extremities in place but one finger will be able to be placed between the infant and the blanket.
BEHAVIORAL	Unswaddled Control	Procedure for control is blanket loosely draped across the infant without providing containment and without touching the anterior surface of the infant.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-01-22
• Last updated: 2017-01-27

Locations

1 site across 1 country: United States