A Prospective Randomized Controlled Tiral Comparing Sprinting Versus Non-sprinting Approach to Wean Nasal Continous Positive Airway Pressure Support in Premature Infants Born at Less Than 30 Weeks Gestational Age
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neonatal Respiratory Distress Syndrome
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Enrollment
- 80
- Primary Endpoint
- Number of Participants With Successful Wean Off CPAP at the First Attempt
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
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
Investigators
Virender Rehan, MD
Chair, Department of Neonatology
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Eligibility Criteria
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.
- •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.
Exclusion Criteria
- •Evidence of a hemodynamically or clinically significant (worsening respiratory status or pulmonary edema on chest x-ray) Patent ductus arteriosus, diagnosed either clinically or echocardiographically.
- •Any significant congenital abnormality (abnormalities affecting a major organ system, airway, or musculoskeletal system).
- •Hemodynamic/respiratory instability or currently being treated for suspected or proven sepsis (positive blood culture)
- •Grade IV intraventricular hemorrhage
- •Inability to obtain informed parental consent
Outcomes
Primary Outcomes
Number of Participants With Successful Wean Off CPAP at the First Attempt
Time Frame: 7 days
Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt.
Secondary Outcomes
- Number of Participants With Bronchopulmonary Dysplasia(1-2 months)
- Number of Participants With Retinopathy of Prematurity (ROP)(1-2 months)
- Number of Participants With Periventricular Leukomalacia (PVL)(1-2 months)
- Length of Stay (Days)(60-108 days)
- Corrected Gestational Age at Time of Discharge/Transfer(36weeks-41weeks)
- Number of Attempts to Wean Off CPAP(Until completely weaned off CPAP)
- Number of Days on Protocol(7-10 days)