A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants

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.

Conditions

• Premature Infants

Interventions

OTHER

RHO

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

Sponsors & Collaborators

• Bay State Medical Center

  collaborator UNKNOWN

• UConn Health

  collaborator OTHER

• University of Vermont Medical Center

  collaborator OTHER

• Connecticut Children's Medical Center

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Tufts Medical Center

  collaborator OTHER

• Westchester Medical Center

  collaborator OTHER

• University of Massachusetts, Worcester

  lead OTHER

Principal Investigators

• Lawrence Rhein, MD, MPH · University of Massachusetts, Worcester

• Heather White, BS · University of Massachusetts, Worcester

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

37 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2017-12-31

Completion

2019-02-28

Countries

• United States

Study Locations