A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants

University of Massachusetts, Worcester

Status: Completed

Conditions: Premature Infants

Treatments: Other: RHO

Study type: Interventional

Funder types: Other

Identifiers

NCT01994954

IP00009772

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Arm A:Standard therapy

No Intervention group

Description:

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.

Arm B:RHO

Experimental group

Description:

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.

Treatment:

Other: RHO