A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
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|ClinicalTrials.gov Identifier: NCT01994954|
Recruitment Status : Enrolling by invitation
First Posted : November 26, 2013
Last Update Posted : July 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Premature Infants||Other: RHO||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
No Intervention: Arm A:Standard therapy
Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities.
Experimental: Arm B:RHO
Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits.
Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography.
Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions.
- Duration of home oxygen use [ Time Frame: Two years from study start date ]We will determine the duration of home oxygen use from time of randomization to discontinuation
- Caregiver quality of life [ Time Frame: Within 6 months of discontinuation of home oxygen therapy ]We will compare the difference between survey-derived quality-of-life, comparing response at 6 months after discontinuation of home oxygen with pre-randomization responses.
- Respiratory-related emergency department visits and rehospitalizations [ Time Frame: WIthin 6 months of discontinuation of home oxygen ]We will assess rates of rehospitalization or ED visit within 6 months of discontinuation of home oxygen.
- Growth parameters [ Time Frame: Within 6 months of discontinuation of home oxygen ]We will assess weight, length, and weight-for-length in patients at the time point 6 months from discontinuation of home oxygen
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994954
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|United States, Kentucky|
|Kentucky Children's Hospital at University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Baystate Medical Center|
|Springfield, Massachusetts, United States, 01199|
|UMass Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03766|
|United States, New York|
|Boston Children's Hospital Physicians|
|Valhalla, New York, United States, 10595|
|United States, Vermont|
|University of Vermont Medical Center|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Lawrence Rhein, MD, MPH||University of Massachusetts, Worcester|
|Study Director:||Heather White, BS||University of Massachusetts, Worcester|