Clinical Trial: Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Ges

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 Summary: 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
Sponsor: Los Angeles Biomedical Research Institute

Current Primary Outcome: Successful wean off NCPAP at the first attempt [ Time Frame: 7 days ]

Measured by no NCPAP requirement after 7 days on protocol


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • BronchoPulmonary Dysplasia [ Time Frame: 1-2 months ]
    Measured as an oxygen requirement at 36 weeks corrected gestational age
  • Retinopathy of Prematurity (ROP) [ Time Frame: 1-2 months ]
    Measured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge
  • Periventricular Leukomalacia (PVL) [ Time Frame: 1-2 months ]
    Measured as radiologic findings of PVL noted prior to discharge
  • Length of Stay (Days) [ Time Frame: 60-108 days ]
    Measures as the number of days patient remained hospitalized after birth at the study hospital.
  • Corrected gestational age at time of discharge/transfer [ Time Frame: 36weeks-41weeks ]
    Measured as the corrected gestational age at which the patient was discharged or transferred.
  • Number of Attempts to Wean off CPAP [ Time Frame: 7-30 days ]
    Measured as the total number of days from the start of NCPAP weaning to the time NCPAP was off.
  • Number of Days on Protocol [ Time Frame: 7-10 days ]
    Measured as the total number of days the patient was on the study protocol


Original Secondary Outcome: Same as current

Information By: Los Angeles Biomedical Research Institute

Dates:
Date Received: May 24, 2016
Date Started: January 2014
Date Completion:
Last Updated: June 27, 2016
Last Verified: June 2016