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.
Eligible infants admitted to two Neonatal Intensive Care Units (NICUs) were randomized to a sprinting (SP) vs. a non-sprinting (NSP) protocol, both over 4 days. Infants assigned to the SP group sprinted twice daily for 3h (day 1), 6h (day 2), 9h (day 3) \& then 24h back on NCPAP (day 4) before switching to nasal cannula (NC) on day 5. Infants in the NSP group were maintained on NCPAP of 5 cm of water for the first 4 days before switching to NC on day 5, similar to the SP group. Infants in both groups were observed for the next 3 days (day 5-7) to ensure stability off CPAP
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Nasal Continuous Positive Airway Pressure
Number of Participants With Successful Wean Off CPAP at the First Attempt
Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt.
Time frame: 7 days
Number of Participants With Bronchopulmonary Dysplasia
Measured as an oxygen requirement at 36 weeks corrected gestational age
Time frame: 1-2 months
Number of Participants With Retinopathy of Prematurity (ROP)
Measured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge
Time frame: 1-2 months
Number of Participants With Periventricular Leukomalacia (PVL)
Measured as radiologic findings of PVL noted prior to discharge
Time frame: 1-2 months
Length of Stay (Days)
Measures as the number of days patient remained hospitalized after birth at the study hospital.
Time frame: 60-108 days
Corrected Gestational Age at Time of Discharge/Transfer
Measured as the corrected gestational age at which the patient was discharged or transferred.
Time frame: 36weeks-41weeks
Number of Attempts to Wean Off CPAP
Number of attempts made to wean off CPAP
Time frame: Until completely weaned off CPAP
Number of Days on Protocol
Measured as the total number of days the patient was on the study protocol
Time frame: 7-10 days
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