Last reviewed · How we verify
NCT04942106
Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position
NA trial testing Arm 1 - Side-lying position followed by Supine position in Feeding, Bottle in 60 participants. Completed in 31 May 2024.
31 May 2024
Quick facts
| Lead sponsor | Boston College |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 10 March 2022 |
| Primary completion | 31 May 2024 |
| Estimated completion | 31 May 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Arm 1 - Side-lying position followed by Supine position
- Arm 2 - Supine position followed by Side-lying position
Conditions studied
- Feeding, Bottle — all drugs for Feeding, Bottle →
- Infant, Premature, Diseases — all drugs for Infant, Premature, Diseases →
- Behavior, Infant — all drugs for Behavior, Infant →
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):
-
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:
- PubMed search for NCT04942106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04942106 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston College
- Last refreshed: 12 July 2024
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