Status:
TERMINATED
Comparison of Oxygen Controllers in Preterm InfanTs
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
University of Tasmania
Conditions:
Premature Infant
Respiratory Insufficiency
Eligibility:
All Genders
Up to 8 years
Phase:
NA
Brief Summary
Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow t...
Detailed Description
Both hypoxemia as hyperoxemia can potentially be harmful to premature infants. Oxygen titration during respiratory support is vital to prevent these conditions but is very challenging. In the investig...
Eligibility Criteria
Inclusion
- Preterm infants with a gestational age (GA) at birth of 24 - 29+6/7 weeks
- Receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV)
- Receiving supplemental oxygen (defined as FiO2 ≥ 0.25) at the time of enrollment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours.
- Expected to complete the 49-hour or 50-hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support
- Written informed parental consent must be present.
Exclusion
- Major congenital anomalies
- Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment.
- If the attending physician considers the infant not stable enough for a switch to another ventilator.
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03877198
Start Date
February 19 2019
End Date
February 13 2020
Last Update
June 9 2020
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333