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NCT01994954 · ClinicalTrials.gov registry record · NA
A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
A NA study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- NA
- Development phase
- 196
- Enrollment target
NCT01994954 is a NA study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 196 participants.
The verdict
NCT01994954, a NA study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- NA
- Development phase
- 196 participants
- Enrollment target
Study Summary
The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management protocols. Evidence-based specific consensus guidelines for home regulated oxygen management do not currently exist. Current strategies for infants requiring outpatient supplemental home oxygen include brief checks of oxygen status during monthly clinic visits. Although the infants stay on monitors, no data in between visits is obtained to ensure that infants can maintain oxygen levels after weans are made. Before finally allowing oxygen to be removed, many centers also require an overnight sleep study in the hospital, to make sure that the infant's oxygen levels stay safe when the infant is in deep sleep. Because these methods rely solely on assumptions rather than individually recorded data, an infant's time on supplemental oxygen may be prolonged or insufficient. This study will evaluate both the currently used accepted therapy and a method of weaning that involves recording and sending oxygen data for analysis in between clinic visits. Premature infants who require home oxygen therapy at time of discharge who meet eligibility criteria will be randomized into two arms: Arm A ("Standard therapy"): Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Arm B (Recorded Home Oximetry (RHO)): Infants will have the same monthly clinic assessments as in Arm A, but also will utilize Recorded Home Oximetry (RHO) to potentially increase, decrease or maintain oxygen between monthly visits. Parents of all infants will be interviewed using structured quality-of-life questionnaires at the beginning and ending of the oxygen management process. Health care utilization (emergency department visits and rehospitalizations) and growth will be assessed 6 months after discontinuation of o
Interventions
- OTHER RHO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2013-11 |
| Est. Completion | 2019-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01994954
The ClinicalTrials.gov registry entry for NCT01994954 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RHO is the first listed.
NCT01994954 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01994954 about?
NCT01994954 is a clinical study titled "A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants". The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management protocols. Evidence-based specific consensus guidelines for home regulated ...
What is the current status of trial NCT01994954?
This trial is currently completed. It is a NA study. The enrollment target is 196 participants. The study started on 2013-11. Estimated completion is 2019-02.
What interventions are being tested in trial NCT01994954?
The interventions under investigation include: RHO (OTHER).
Who is sponsoring clinical trial NCT01994954?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
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