A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
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|ClinicalTrials.gov Identifier: NCT01994954|
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
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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)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||February 2019|
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 Therapy [ Time Frame: NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months. ]Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT).
- Caregiver Quality of Life [ Time Frame: Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy ]We will compare the difference between survey-derived quality-of-life scores, comparing parent response averages while on home oxygen therapy (HOT) versus 3 months post oxygen discontinuation scores in both arms. The infant scale is composed of 36 items comprising 5 dimensions. The item scaling is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores range from 0 to 100, with a higher score indicating a higher parent satisfaction and quality of life.
- Participants With 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 throughout the weaning process and continue to assess until 6 months post discontinuation.
- Growth Parameters [ Time Frame: Enrollment to 6 months post home oxygen therapy discontinuation ]Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight z-score change was found in both arms for pre and post weaning from home oxygen therapy. The weight z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
- Growth Parameters, Weight-for-length Z-score Change [ Time Frame: Enrollment through 6 months post discontinuation of home oxygen therapy ]Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight for length z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight for length z-score change was found in both arms for pre and post weaning from home oxygen therapy.The weight-for-length z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
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|Ages Eligible for Study:||up to 37 Weeks (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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|
Documents provided by Lawrence Rhein, University of Massachusetts, Worcester:
|Responsible Party:||Lawrence Rhein, Principal Investigator, University of Massachusetts, Worcester|
|Other Study ID Numbers:||
|First Posted:||November 26, 2013 Key Record Dates|
|Results First Posted:||October 2, 2019|
|Last Update Posted:||October 2, 2019|
|Last Verified:||September 2019|
newborn intensive care unit
Obstetric Labor, Premature
Obstetric Labor Complications
Female Urogenital Diseases and Pregnancy Complications