Effects of Swaddling on Infants During Feeding

Premature Birth Clinical Trial

Official title:

Effects of Swaddling During Bottle Feeding on Infants Born Preterm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661360
• Other study ID #: 15-00493
• Status: Completed
• Phase: N/A
• First received: January 20, 2016
• Last updated: January 26, 2017
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.
• Unswaddled Control
Procedure for control is blanket loosely draped across the infant without providing containment and without touching the anterior surface of the infant.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS)		1 Day
Primary	Feeding engagement measured by subtest of Early Feeding Skills Assessment (EFS)		1 Day
Primary	Oral motor organization measured by subtest of Early Feeding Skills Assessment (EFS)		1 Day
Primary	Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)		1 Day
Primary	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
Primary	Feeding recovery measured by subtest of Early Feeding Skills Assessment (EFS)		1 Day
Primary	Number of significant changes in heart rate (bradycardia		1 Day
Primary	Number of significant oxygen desaturations		1 Day