Clinical trial NCT02661360: Effects of Swaddling on Infants During Feeding
Official title: Effects of Swaddling During Bottle Feeding on Infants Born Preterm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: swaddling
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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:

  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

Primary outcomes:
measure: Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS)
timeFrame: 1 Day
measure: Feeding engagement measured by subtest of Early Feeding Skills Assessment (EFS)
timeFrame: 1 Day
measure: Oral motor organization measured by subtest of Early Feeding Skills Assessment (EFS)
timeFrame: 1 Day
measure: Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)
timeFrame: 1 Day
measure: Physiologic stability measured by subtest of Early Feeding Skills Assessment (EFS)
timeFrame: 1 Day
measure: Feeding recovery measured by subtest of Early Feeding Skills Assessment (EFS)
timeFrame: 1 Day
measure: Number of significant changes in heart rate (bradycardia
timeFrame: 1 Day
measure: Number of significant oxygen desaturations
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Steve Vanlew, MD
role: PRINCIPAL_INVESTIGATOR
References: