Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants (NCT02819050) | Clinical Trial Compass
CompletedNot Applicable
Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
80 participantsStarted 2014-01
Plain-language summary
Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP off in infants born between 23 0/7-30 6/7 weeks of gestational age.
Who can participate
Age range26 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Born between 23 0/7 - 30 6/7 weeks GA
* At least 26 0/7 weeks corrected GA.
* On NCPAP for at least 24 hours
* Stable on ≤0.3 FiO2 for at least 24 hours
Initiation of study protocol, i.e., weaning from NCPAP, was started when infant met all of the following criteria for at least 24 hours:
* Requiring NCPAP of 4-6 cm of H2O and FiO2 ≤0.3.
* All babies \< 32 weeks corrected GA should have been loaded or already on maintenance caffeine (caffeine citrate 20 mg/kg as the loading and 5-10 mg/kg as the maintenance dose).
* Stable respiratory system assessment (respiratory rate of \< 70/min, no significant chest retractions (sternal/ diaphragmatic), and baseline oxygen saturation \> 86%) and otherwise deemed clinically stable for weaning off non-invasive ventilation by medical team
* If post-surgery, infant must be at least 2 weeks post-operative and off antibiotics with no concern or need for repeat surgery.
* A documented hemoglobin of more than 8 g/dl within 7 days of initiation of the study.
* Meeting "stability criteria" defined below:
* The infant had to be tolerating a flow of no more than 2 liters NC on a FiO2 of 0.30 or less to keep oxygen saturations above 85% (should match what you wrote below in failure criteria)%.
* Have a respiratory rate of less than 70 on average over 24 hours for more than 24 hours
* The infant could have no significant chest recession (sternal/diaphragmatic)
Exclusion Criteria:
* Evidence of a hemodynamically or cli…
What they're measuring
1
Number of Participants With Successful Wean Off CPAP at the First Attempt
Timeframe: 7 days
Trial details
NCT IDNCT02819050
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center