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NCT04942106 · ClinicalTrials.gov registry record · NA
Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position
A NA study, sponsored by Boston College.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT04942106 is a NA study that has completed, run by Boston College. The registered enrollment target is 60 participants.
The verdict
NCT04942106, a NA study, has completed, sponsored by Boston College.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Arm 1 - Side-lying position followed by Supine position
- OTHER Arm 2 - Supine position followed by Side-lying position
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2024-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04942106
The ClinicalTrials.gov registry entry for NCT04942106 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston College, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Arm 1 - Side-lying position followed by Supine position is the first listed.
NCT04942106 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04942106 about?
NCT04942106 is a clinical study titled "Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position". 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...
What is the current status of trial NCT04942106?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2022-03-10. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT04942106?
The interventions under investigation include: Arm 1 - Side-lying position followed by Supine position (OTHER), Arm 2 - Supine position followed by Side-lying position (OTHER).
Who is sponsoring clinical trial NCT04942106?
This trial is sponsored by Boston College, which has 18 total clinical trials registered on ClinicalTrials.gov.
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