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

Not Applicable

Completed

• Conditions: BronchoPulmonary Dysplasia; Neonatal Respiratory Distress Syndrome; Extremely Low Birth Weight Infant (ELBW)
• Interventions: Device: NCPAP

• Registration Number: NCT02819050
• Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-30
• Results First Submitted: 2017-10-12
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-08
• Last Update Submitted: 2021-12-08
• Results First Posted: 2021-12-10
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Sprinting	NCPAP	* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC. * If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
Sprinting	NCPAP	Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Wean Off CPAP at the First Attempt	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 Outcome Measures

Name	Time	Method
Number of Participants With Bronchopulmonary Dysplasia	1-2 months	Measured as an oxygen requirement at 36 weeks corrected gestational age
Number of Participants With Retinopathy of Prematurity (ROP)	1-2 months	Measured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge
Number of Participants With Periventricular Leukomalacia (PVL)	1-2 months	Measured as radiologic findings of PVL noted prior to discharge
Length of Stay (Days)	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	36weeks-41weeks	Measured as the corrected gestational age at which the patient was discharged or transferred.
Number of Attempts to Wean Off CPAP	Until completely weaned off CPAP	Number of attempts made to wean off CPAP
Number of Days on Protocol	7-10 days	Measured as the total number of days the patient was on the study protocol