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4 BACKGROUND  6 PARTICIPATION OF PATIENTS AND OTHER STAKEHOLDERS  10 Stakeholder Engagement  10 Parent Advisory Board  11 Data and Safety Monitoring Board  11 METHODS  12 Study Overview  12 Table 1. Oxygen Weaning Parameters  14 Eligibility and Recruitment  14 Randomization  15 Interventions and Controls  16 Interventions  17 Study Outcomes  20 Covariates  21 Statistical Methods  21 Table 2. Justification of Power Calculation for the RHO Trial  22 RESULTS  26 Baseline Characteristics  26 Figure 1. Flow Diagram of Recruitment for the RHO Trial  27 Table 3. Study Cohort Demographics  28 Specific Aim 1: To Evaluate Impact of Data-Driven HOT Management Protocol on Duration of HOT  29 Figure 2a. Duration of HOT by Randomized Arm  31 Figure 2b. Percentage Weaned From Oxygen Within Set Categories  31 Figure 2c. Duration of HOT by RHO Reports Per Month  32 Figure 2d. Comparison of Duration on HOT by Arm and Initial O2 Flow Rate  32 Specific Aim 2: To Evaluate Effects of Data-Driven HOT Management Protocol on Parental QOL  33 Table 4. Parents’ QOL Scores (PedsQL) During and After Weaning  34 Specific Aim 3: To Evaluate Extent to Which Data-Driven HOT Management Protocol Affects Growth and Respiratory Outcomes  34

Monitoring Oxygen Levels of Premature Babies at Home and in the Clinic—The RHO Trial