NCT02661360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

January 20, 2016

Last Update Submit

January 26, 2017

Conditions

Premature Birth

Keywords

swaddling

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

Starting condition of swaddled

EXPERIMENTAL
Behavioral: Swaddling Intervention for Preterm InfantsBehavioral: Unswaddled Control

Starting Condition of Unswaddled

EXPERIMENTAL
Behavioral: Swaddling Intervention for Preterm InfantsBehavioral: Unswaddled Control

Interventions

Swaddling Intervention for Preterm InfantsBEHAVIORAL

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.

Starting Condition of UnswaddledStarting condition of swaddled
Unswaddled ControlBEHAVIORAL

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

Starting Condition of UnswaddledStarting condition of swaddled

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Steve Vanlew, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 22, 2016

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

US(1)