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Effects of Swaddling on Infants During Feeding

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Swaddling Intervention for Preterm Infants
Unswaddled Control
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth focused on measuring swaddling

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Starting condition of swaddled

Starting Condition of Unswaddled

Arm Description

Outcomes

Primary Outcome Measures

Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS)
Feeding engagement measured by subtest of Early Feeding Skills Assessment (EFS)
Oral motor organization measured by subtest of Early Feeding Skills Assessment (EFS)
Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)
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
Feeding recovery measured by subtest of Early Feeding Skills Assessment (EFS)
Number of significant changes in heart rate (bradycardia
Number of significant oxygen desaturations

Secondary Outcome Measures

Full Information

First Posted
January 20, 2016
Last Updated
January 26, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02661360
Brief Title
Effects of Swaddling on Infants During Feeding
Official Title
Effects of Swaddling During Bottle Feeding on Infants Born Preterm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
swaddling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Starting condition of swaddled
Arm Type
Experimental
Arm Title
Starting Condition of Unswaddled
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Swaddling Intervention for Preterm Infants
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Unswaddled Control
Intervention Description
Procedure for control is blanket loosely draped across the infant without providing containment and without touching the anterior surface of the infant.
Primary Outcome Measure Information:
Title
Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS)
Time Frame
1 Day
Title
Feeding engagement measured by subtest of Early Feeding Skills Assessment (EFS)
Time Frame
1 Day
Title
Oral motor organization measured by subtest of Early Feeding Skills Assessment (EFS)
Time Frame
1 Day
Title
Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)
Time Frame
1 Day
Title
Physiologic stability measured by subtest of Early Feeding Skills Assessment (EFS)
Description
Stability of heart rate and respiratory rate are indicative of the ability of the infant born preterm to cope with stress during bottle feeding
Time Frame
1 Day
Title
Feeding recovery measured by subtest of Early Feeding Skills Assessment (EFS)
Time Frame
1 Day
Title
Number of significant changes in heart rate (bradycardia
Time Frame
1 Day
Title
Number of significant oxygen desaturations
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Grades III and IV intraventricular hemorrhage Necrotizing enterocolitis Congenital cardiac anomalies (except medically managed patent ductus arteriosus) Genetic syndromes Craniofacial abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Vanlew, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Swaddling on Infants During Feeding

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