Effects of Swaddling on Infants During Feeding



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:September 2015
End Date:September 2017
Contact:Allison Smith
Email:smitha23@nyumc.org

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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.

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.

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
We found this trial at
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Steve Vanlew, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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