Effects of Swaddling on Infants During Feeding

Completed · Not applicable

Conditions studied: Premature Birth

In brief

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.

Key facts

Study ID

NCT02661360

Run by

NYU Langone Health

People needed

30

Starts

2015-09-01

Expected to finish

2016-04-01

Last updated by the study team

2017-01-27

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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