Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
1 other identifier
interventional
226
1 country
1
Brief Summary
The purpose of this study is to determine an optimal strategy to wean nasal continuous positive airway pressure (NCPAP) in preterm babies. The investigators hypothesize that babies that are taken off NCPAP at lower settings will need fewer total days on NCPAP than those babies taken off at higher settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedOctober 22, 2018
October 1, 2018
3.7 years
February 14, 2014
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total days of NCPAP
Total number of days of CPAP therapy during the hospital stay
Until hospital discharge or 1 year of life
Secondary Outcomes (2)
Length of hospital stay
Until hospital discharge or 1 year of life
Duration of oxygen supplementation
Until hospital discharge or 1 year of life
Study Arms (2)
Low CPAP Wean
ACTIVE COMPARATORNCPAP weaned to 5cm H2O for minimum of 24h, and if the neonate remains clinically stable as defined, wean in 1cm increments to 3cm H2O for minimum of 24h, at which time move to room air or 1L/min nasal cannula if supplemental O2 is required.
High CPAP Wean
ACTIVE COMPARATORNCPAP weaned to 5cm H2O for a minimum of 24h, and if the neonate remains clinically stable, move to room air or 1L/min nasal cannula if supplemental O2 is required.
Interventions
Eligibility Criteria
You may qualify if:
- Neonates ≤32wks GA requiring NCPAP in the delivery room or NICU for increasing respiratory distress or post-extubation from mechanical ventilation.
You may not qualify if:
- Neonates requiring NCPAP for less than 48 hours
- Congenital anomalies
- Need for surgery
- Transfer to a different facility
- Grade 3-4 intraventricular hemorrhage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
Related Publications (1)
Kakkilaya V, Tang A, Wagner S, Ridpath J, Ibrahim J, Brown LS, Rosenfeld CR. Discontinuing Nasal Continuous Positive Airway Pressure in Infants </=32 Weeks of Gestational Age: A Randomized Control Trial. J Pediatr. 2021 Mar;230:93-99.e3. doi: 10.1016/j.jpeds.2020.10.045. Epub 2020 Oct 28.
PMID: 33127365DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Venkat Kakkilaya, MD
UT Southwestern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 17, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2018
Study Completion
October 1, 2018
Last Updated
October 22, 2018
Record last verified: 2018-10