Last reviewed · How we verify

NCT04942106

Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

Completed NA Last updated 12 July 2024
What this trial tests

NA trial testing Arm 1 - Side-lying position followed by Supine position in Feeding, Bottle in 60 participants. Completed in 31 May 2024.

Timeline
10 March 2022
Primary endpoint
31 May 2024
31 May 2024

Quick facts

Lead sponsorBoston College
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposesupportive care
Enrollment60
Start date10 March 2022
Primary completion31 May 2024
Estimated completion31 May 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Boston College

Who can join

Under 2 Months, any sex, with Feeding, Bottle or Infant, Premature, Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. As an exploratory aim, the investigators will also identify potential infant characteristics associated with the intervention response by evaluating infant sex, maturity level, and/or comorbidity. The two bottle-feeding positions will be the semi-elevated side-lying position (hereafter referred to as side-lying position) and the semi-elevated supine position (hereafter referred to as supine position), which is the traditional feeding position when preterm infants are bottle-fed. The investigators hypothesize that compared to the supine position, the side-lying position will be associated with greater physiologic stability in heart rate, respiratory rate, oxygen saturation, and/or autonomic nervous system regulation during and after feeding. The investigators also hypothesize that compared to the supine position, the side-lying position will be associated with more mature patterns of suck-breathe coordination and/or greater feeding skills.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Biobehavioral Efficacy of the Elevated Side-Lying Position for Feeding Preterm Infants: Study Protocol.
    Park J, Thoyre S, Smallcomb J, Mcternan M, et al · · 2025 · cited 1× · PMID 39231735 · DOI 10.1111/jan.16444

Verify or expand the search:

Other Boston College trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04942106.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing