Clinical trial NCT02819050: Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
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 Gestational Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Respiratory Distress Syndrome
Extremely Low Birth Weight Infant (ELBW)
BronchoPulmonary Dysplasia
Keywords: CPAP
Extremely Low Birth Weight Infant (ELBW)
Non-invasive respiratory support
Premature infants
Non invasive ventilation weaning
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Orange County
First posted: 2016-06-30
Enrollment: 80
Sex: ALL
Minimum age (years): 26
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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 ≤0.3.
* 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 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

Primary outcomes:
measure: Number of Participants With Successful Wean Off CPAP at the First Attempt
timeFrame: 7 days
Secondary outcomes:
measure: Number of Participants With Bronchopulmonary Dysplasia
timeFrame: 1-2 months
measure: Number of Participants With Retinopathy of Prematurity (ROP)
timeFrame: 1-2 months
measure: Number of Participants With Periventricular Leukomalacia (PVL)
timeFrame: 1-2 months
measure: Length of Stay (Days)
timeFrame: 60-108 days
measure: Corrected Gestational Age at Time of Discharge/Transfer
timeFrame: 36weeks-41weeks
measure: Number of Attempts to Wean Off CPAP
timeFrame: Until completely weaned off CPAP
measure: Number of Days on Protocol
timeFrame: 7-10 days
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Virender Rehan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Singh SD, Bowe L, Clarke P, Glover K, Pasquill A R, MJ et al. Is decreasing pressure or increasing time off the better strategy in weaning VLBW infants from nasal CPAP? Eur J Pediatr B Abstr Eur Acad Pediatr. 2006;Abstract.
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citation: Rastogi S, Wong W, Gupta A, Bhutada A; Deepa Rastogi; Maimonides Neonatal Group. Gradual versus sudden weaning from nasal CPAP in preterm infants: a pilot randomized controlled trial. Respir Care. 2013 Mar;58(3):511-6. doi: 10.4187/respcare.01999.
citation: Eze N, Murphy D, Dhar V, Rehan VK. Comparison of sprinting vs non-sprinting to wean nasal continuous positive airway pressure off in very preterm infants. J Perinatol. 2018 Feb;38(2):164-168. doi: 10.1038/jp.2017.161. Epub 2017 Oct 26.