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A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994954
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Bay State Medical Center
UConn Health
University of Vermont Medical Center
Connecticut Children's Medical Center
Patient-Centered Outcomes Research Institute
University of Kentucky
Boston Children’s Hospital
Dartmouth-Hitchcock Medical Center
Tufts Medical Center
Westchester Medical Center
Information provided by (Responsible Party):
Lawrence Rhein, University of Massachusetts, Worcester

Brief 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.


Condition or disease Intervention/treatment Phase
Premature Infants Other: RHO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : November 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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.

Other: RHO
Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of Massachusetts, Worcester
Bay State Medical Center
UConn Health
University of Vermont Medical Center
Connecticut Children's Medical Center
Patient-Centered Outcomes Research Institute
University of Kentucky
Boston Children’s Hospital
Dartmouth-Hitchcock Medical Center
Tufts Medical Center
Westchester Medical Center
Investigators
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Principal Investigator: Lawrence Rhein, MD, MPH University of Massachusetts, Worcester
Study Director: Heather White, BS University of Massachusetts, Worcester
  Study Documents (Full-Text)

Documents provided by Lawrence Rhein, University of Massachusetts, Worcester:
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Responsible Party: Lawrence Rhein, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01994954    
Other Study ID Numbers: IP00009772
First Posted: November 26, 2013    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: September 2019
Keywords provided by Lawrence Rhein, University of Massachusetts, Worcester:
newborn intensive care unit
NICU
supplemental oxygen
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications