Clinical trial NCT01994954: A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Keywords: newborn intensive care unit
NICU
supplemental oxygen
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Bay State Medical Center
name: UConn Health
name: University of Vermont Medical Center
name: Connecticut Children's Medical Center
name: Patient-Centered Outcomes Research Institute
name: University of Kentucky
name: Boston Children's Hospital
name: Dartmouth-Hitchcock Medical Center
name: Tufts Medical Center
name: Westchester Medical Center
First posted: 2013-11-26
Enrollment: 196
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Duration of Home Oxygen Therapy
timeFrame: NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months.
measure: Caregiver Quality of Life
timeFrame: Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy
Secondary outcomes:
measure: Participants With Respiratory-related Emergency Department Visits and Rehospitalizations
timeFrame: WIthin 6 months of discontinuation of home oxygen
measure: Growth Parameters
timeFrame: Enrollment to 6 months post home oxygen therapy discontinuation
measure: Growth Parameters, Weight-for-length Z-score Change
timeFrame: Enrollment through 6 months post discontinuation of home oxygen therapy
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Lexington
country: United States
facility: Kentucky Children's Hospital at University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Valhalla
country: United States
facility: Boston Children's Hospital Physicians
state: New York
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of Massachusetts, Worcester
name: Lawrence Rhein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Heather White, BS
role: STUDY_DIRECTOR
References: