N/A
N=196
A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
Premature Infants
Bottom Line
View on ClinicalTrials.gov: NCT01994954 ↗Enrolled (actual)
196
Serious AEs
24.0%
Results posted
Oct 2019
Primary outcome: Primary: Duration of Home Oxygen Therapy — 66; 58 Days — p=<0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RHO (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Home Oxygen Therapy |
66; 58 | <0.03 sig |
| PRIMARY Caregiver Quality of Life |
74.5; 70.4; 78.6; 75.9 | 0.38 |
| SECONDARY Participants With Respiratory-related Emergency Department Visits and Rehospitalizations |
41; 25; 28; 19; 7; 6 | — |
| SECONDARY Growth Parameters |
-0.13; -0.01; 0.02; 0.03 | — |
| SECONDARY Growth Parameters, Weight-for-length Z-score Change |
-0.17; -0.06; -0.14; 0.01 | — |
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 oxygen.
The investigators overall objective is to determine whether Recorded Home Oximetry (RHO) can improve caregiver quality of life, and can shorten Home Oxygen Therapy (HOT) duration and eliminate need for polysomnogram, without compromising safety. The investigators will determine respiratory-related re-hospitalizations, emergency department (ED) visits, and growth parameters to confirm safety of the proposed weaning strategies.
Eligibility Criteria
Inclusion Criteria
- Infant with birth gestational age ≤ 37 (37 0/7) wks postmenstrual age (PMA) who has requirement for supplemental O2 at time of NICU discharge, as determined by primary NICU team.
- Infant receiving pediatric pulmonology care at the Center for Healthy Infant Lung Development
- Parent aged 18 years or older
- English or Spanish-speaking.
Exclusion Criteria
- Parents whose infants has presence of pulmonary hypertension at enrollment
- Parents whose infant with syndrome or other diagnosis with known high risk for persistent hypoxia (cardiac disease, Trisomy 21, Pierre-Robin Sequence, etc.)
- Parents whose infant has requirement for O2 flow rate > 1 L/min or tracheostomy
- Any infants who also require caffeine at discharge from the NICU
Data sourced from ClinicalTrials.gov (NCT01994954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.