Effects of Swaddling on Infants During Feeding

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Behavioral: Swaddling Intervention for Preterm Infants; Behavioral: Unswaddled Control

• Registration Number: NCT02661360
• Lead Sponsor: NYU Langone Health

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-22
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• all infants born before 34 weeks gestational age will be included as long as they do not have any exclusion criteria
• infants born before 34 weeks gestational age is 33 weeks 3 days to 35 weeks 0 days, with attainment of exclusive bottle feeding at 36 weeks gestational age at the earliest.
• Infants who are multiples will be included but restricted to twins and triplets.
• Infants will only be included if their parents provide informed consent for participation of their infant in the study.

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Exclusion Criteria

The exclusion criteria are factors commonly associated with feeding problems in infants beyond prematurity, including:

• Infants who are exclusively breastfed

• Higher order multiples than twins and triplets (ie. quadruplets)

• Infants with conditions that may affect feeding performance:

  1. Grades III and IV intraventricular hemorrhage
  2. Necrotizing enterocolitis
  3. Congenital cardiac anomalies (except medically managed patent ductus arteriosus)
  4. Genetic syndromes
  5. Craniofacial abnormalities

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Starting Condition of Unswaddled	Swaddling Intervention for Preterm Infants	-
Starting Condition of Unswaddled	Unswaddled Control	-
Starting condition of swaddled	Swaddling Intervention for Preterm Infants	-
Starting condition of swaddled	Unswaddled Control	-

Primary Outcome Measures

Name	Time	Method
Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)	1 Day
Physiologic stability measured by subtest of Early Feeding Skills Assessment (EFS)	1 Day	Stability of heart rate and respiratory rate are indicative of the ability of the infant born preterm to cope with stress during bottle feeding
Feeding recovery measured by subtest of Early Feeding Skills Assessment (EFS)	1 Day
Number of significant oxygen desaturations	1 Day
Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS)	1 Day
Number of significant changes in heart rate (bradycardia	1 Day
Oral motor organization measured by subtest of Early Feeding Skills Assessment (EFS)	1 Day
Feeding engagement measured by subtest of Early Feeding Skills Assessment (EFS)	1 Day

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States