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

December 8, 2021 updated by: Virender Rehan, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sprinting
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)
Device: NCPAP
Nasal Continuous Positive Airway Pressure
ACTIVE_COMPARATOR: Non-Sprinting
  • 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.
Device: NCPAP
Nasal Continuous Positive Airway Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Bronchopulmonary Dysplasia
Time Frame: 1-2 months
Measured as an oxygen requirement at 36 weeks corrected gestational age
1-2 months
Number of Participants With 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
1-2 months
Number of Participants With Periventricular Leukomalacia (PVL)
Time Frame: 1-2 months
Measured as radiologic findings of PVL noted prior to discharge
1-2 months
Length of Stay (Days)
Time Frame: 60-108 days
Measures as the number of days patient remained hospitalized after birth at the study hospital.
60-108 days
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.
36weeks-41weeks
Number of Attempts to Wean Off CPAP
Time Frame: Until completely weaned off CPAP
Number of attempts made to wean off CPAP
Until completely weaned off CPAP
Number of Days on Protocol
Time Frame: 7-10 days
Measured as the total number of days the patient was on the study protocol
7-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborators

Children's Hospital of Orange County

Investigators

  • Principal Investigator: Virender Rehan, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (ESTIMATE)

June 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30166-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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