The optimization of home oxygen weaning in premature infants trial: Design, rationale, methods, and lessons learned

Contemp Clin Trials. 2018 Dec:75:72-77. doi: 10.1016/j.cct.2018.08.001. Epub 2018 Aug 11.

Abstract

Improved survival among preterm infants has led to an increase in diagnosis of chronic lung disease and infants discharged home from the NICU on supplemental oxygen. Despite this increased prevalence, no clearly defined guidelines for the management of home oxygen therapy (HOT) exist. This lack of consensus leads to significant variability in the duration of home oxygen therapy and a general paucity of evidence-based practice. Our team has identified recorded home oxygen therapy (RHO) as a potential new resource to guide clinical decision making in the outpatient pulmonology clinic. By recording extended O2 saturation data during the weaning process, RHO has the potential to save cost and improve the processes of HOT management. Our team is currently supporting a prospective, multi-center, randomized, controlled trial of RHO guided HOT weaning with the aims of determining effect upon duration of HOT, perceived parent quality of life and effect upon growth and respiratory outcomes. We plan to randomize 196 infants into one of two study arms evaluating standard HOT management versus RHO guided oxygen weaning. Our primary outcomes are total HOT duration and parental quality of life. This trial represents an unprecedented opportunity to test a novel home monitoring intervention for weaning within a vulnerable yet quickly growing population. If effective, the use of RHO may provide clinicians a tool for safe weaning.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bronchopulmonary Dysplasia / rehabilitation*
  • Home Care Services
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature
  • Oximetry / methods*
  • Oxygen Inhalation Therapy / methods*
  • Parents
  • Patient Discharge
  • Polysomnography
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Time Factors