Status:
WITHDRAWN
The Effects of Home Monitors Used with Home Oxygen Therapy
Lead Sponsor:
University of New Mexico
Conditions:
Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's Home
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study\'s purpose is to determine the effects of using monitors with home oxygen therapy (HOT). This trial will test the hypothesis that infants discharged from the neonatal intensive care uni...
Detailed Description
This will be a randomized control trial in which infants being discharged from the neonatal intensive care unit with home oxygen therapy will be placed in one of two groups. Those randomized into the ...
Eligibility Criteria
Inclusion
- • Infants being discharged with home oxygen therapy.
- Infants born at other institutions and then transferred to UNMH will be eligible if discharged home with home oxygen therapy.
- Infants born at gestational age 28 0/7 weeks or greater.
- Infants of employees of the UNMH will be allowed to participate in the study but will not be targeted. All efforts will be made to ensure that no coercion or undue influence will be used in recruiting this population.
Exclusion
- • Infants diagnosed with conditions that will predispose them to prolonged hypoxemia; examples include cardiac anomaly, anatomic anomalies affecting the airway, tracheostomy dependency, cystic fibrosis, and trisomy 21.
- Infants discharged with hospice care / palliative services.
- Infants discharged greater than 6 months after they were born.
- Parents less than 18 years old or prisoners.
- Parents who are unable to provide consent due to having a legal representative.
- Infants who are in foster care and/or are wards of the state.
- Families not fluent in English.
Key Trial Info
Start Date :
February 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06492382
Start Date
February 8 2025
End Date
March 1 2026
Last Update
March 11 2025
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