Effects of Swaddling on Infants During Feeding

Effects of Swaddling During Bottle Feeding on Infants Born Preterm

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Swaddling Intervention for Preterm Infants; Behavioral: Unswaddled Control

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Starting condition of swaddled	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.
Experimental: Starting Condition of Unswaddled	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Steve Vanlew, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: swaddling
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 15-00493