A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants

Status:	Enrolling by invitation
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	Any
Updated:	7/19/2018
Start Date:	November 2013
End Date:	July 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.

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

We found this trial at

sites

Boston Children's Hospital Physicians

Valhalla, New York 10595

from

Valhalla, NY