A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants

NCT01994954 | Completed Results DMC

• 1 other identifier: IP00009772
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 8

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.

Conditions

Premature Infants

Keywords

newborn intensive care unit; NICU; supplemental oxygen

Outcome Measures

Primary Outcomes (2)

• Duration of Home Oxygen Therapy

  Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT).

  NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months.

• Caregiver Quality of Life

  We will compare the difference between survey-derived quality-of-life scores, comparing parent response averages while on home oxygen therapy (HOT) versus 3 months post oxygen discontinuation scores in both arms. The infant scale is composed of 36 items comprising 5 dimensions. The item scaling is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores range from 0 to 100, with a higher score indicating a higher parent satisfaction and quality of life.

  Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy

Secondary Outcomes (3)

• Participants With Respiratory-related Emergency Department Visits and Rehospitalizations

  WIthin 6 months of discontinuation of home oxygen

• Growth Parameters

  Enrollment to 6 months post home oxygen therapy discontinuation

• Growth Parameters, Weight-for-length Z-score Change

  Enrollment through 6 months post discontinuation of home oxygen therapy

Study Arms (2)

Arm A:Standard therapy

NO INTERVENTION

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

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

Interventions

RHO OTHER

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

Arm B:RHO

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Bay State Medical Center: collaborator
• UConn Health: collaborator
• University of Vermont Medical Center: collaborator
• Connecticut Children's Medical Center: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• University of Kentucky: collaborator
• Boston Children's Hospital: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Tufts Medical Center: collaborator
• Westchester Medical Center: collaborator

Study Sites (8)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Kentucky Children's Hospital at University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Boston Children's Hospital Physicians

Valhalla, New York, 10595, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Lawrence Rhein
• Organization: University of Massachusetts Medical School

Lawrence.Rhein@umassmemorial.org

508-334-6206

Study Officials

• Lawrence Rhein, MD, MPH

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Heather White, BS

  University of Massachusetts, Worcester

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: November 26, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2019
• Last Updated: May 30, 2023
• Results First Posted: October 2, 2019

Record last verified: 2023-05

Locations

US (8)