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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
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
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)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : November 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

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 use [ Time Frame: Two years from study start date ]
    We will determine the duration of home oxygen use from time of randomization to discontinuation

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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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
Boston Children’s Hospital
Bay State Medical Center
UConn Health
University of Vermont Medical Center
Connecticut Children's Medical Center
Patient-Centered Outcomes Research Institute
University of Kentucky
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

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Responsible Party: Lawrence Rhein, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01994954     History of Changes
Other Study ID Numbers: IP00009772
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
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