- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02064712
Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective randomized control trial to investigate an optimal method for discontinuing NCPAP therapy in preterm neonates. Neonates ≤32 weeks gestational age (GA) who require NCPAP in the delivery room or following extubation and are delivered in or transferred to Parkland Hospital Neonatal Intensive Care Unit (NICU) will be enrolled. The study team will approach the parents for verbal consent once neonates are stable on mechanical ventilation with a goal of extubation to NCPAP or once they are placed on initial NCPAP therapy. Neonates will be randomized to the high or low NCPAP arms and managed by their primary care team until they meet stability criteria as defined for a minimum of 12 hours. At that time they will be removed from NCPAP using two approaches: Group 1 will be decreased to 5cm H2O by the primary care team at which time NCPAP is removed if the neonate is clinically stable and the neonate placed in room air or on low-flow nasal cannula at ≤1L/min; Group 2 will be gradually weaned to a NCPAP of 3cm H2O at which time NCPAP is removed if the neonate is clinically stable for the prior 24 hours and the neonate placed in room air or on low-flow nasal cannula. Failure criteria will consist of clinical signs and laboratory results demonstrating the need for escalation of support, e.g., increasing apnea of prematurity (AOP) or need for increasing O2 supplementation. When a neonate has been stable for 5 days off NCPAP, they will complete the intervention arm of the study. All neonates will be followed until discharge, at which time the primary outcomes, e.g., days on NCPAP, duration of hospitalization and need for O2, will be determined for each group and compared. The calculated total sample size will require 238 neonates; i.e., 113 neonates per arm with a 5% drop-out rate will give a power of 0.80 and alpha value of 0.05 to detect a 25% difference in NCPAP days.
Stability Criteria:
- NCPAP 5cm H2O
- Supplemental oxygen <25% and not increasing
- Respiratory rate ≤60 b/min
- No significant respiratory distress, e.g., retractions, dyspnea
- <3 episodes of apnea (>20 seconds) with bradycardia (<100 beats/min), and/or desaturations (<88%) within 1h or <5 episodes in prior 12h
- Average oxygen saturation >87% with stable inspired O2
- Tolerate time off NCPAP during routine care procedures
- Neonates <27 wks GA must be ≥10d postnatal before weaning
Failure Criteria:
- Occurrence of ≥3 apneas and/or bradycardia and/or desaturations within 1h or >4 episodes in a 12h period
- Increasing need for supplemental O2 >30% to maintain O2 saturation >87%
- Increase in the PaCO2 >65 mmHg
- Increased work of breathing with respiratory rate >75 b/min for >2h
- AOP requiring resuscitation
- Initiation of nasal intermittent positive pressure ventilation (NIPPV) for respiratory support
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Parkland Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Neonates ≤32wks GA requiring NCPAP in the delivery room or NICU for increasing respiratory distress or post-extubation from mechanical ventilation.
Exclusion Criteria:
- Neonates requiring NCPAP for less than 48 hours
- Congenital anomalies
- Need for surgery
- Transfer to a different facility
- Grade 3-4 intraventricular hemorrhage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Low CPAP Wean
NCPAP 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.
|
Infants receive NCPAP by Hudson nasal prongs.
|
ACTIVE_COMPARATOR: High CPAP Wean
NCPAP 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.
|
Infants receive NCPAP by Hudson nasal prongs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total days of NCPAP
Time Frame: Until hospital discharge or 1 year of life
|
Total number of days of CPAP therapy during the hospital stay
|
Until hospital discharge or 1 year of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay
Time Frame: Until hospital discharge or 1 year of life
|
Number of days spent prior to being discharged from the hospital
|
Until hospital discharge or 1 year of life
|
Duration of oxygen supplementation
Time Frame: Until hospital discharge or 1 year of life
|
Number of days
|
Until hospital discharge or 1 year of life
|
Collaborators and Investigators
Investigators
- Principal Investigator: Venkat Kakkilaya, MD, UT Southwestern
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NCPAPwean
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.
Clinical Trials on Infant, Premature
-
University of MiamiPontificia Universidad Catolica de ChileTerminated
-
Johnson & Johnson Pharmaceutical Research & Development...TerminatedInfant, Premature | Infant, Newborn
-
NICHD Neonatal Research NetworkNational Center for Research Resources (NCRR)CompletedSepsis | Infant, Small for Gestational Age | Infant, Premature | Infant, Low Birth Weight | Infant, NewbornUnited States
-
Aydin Adnan Menderes UniversityCompletedNursing Caries | Infant Development | Premature Infant Disease | Patient ComfortTurkey
-
University of VirginiaRecruitingDevelopment, Infant | Premature Infant DiseaseUnited States
-
Universidad de LeónCompletedPremature Birth | Premature Infant | Massage | Preterm Infant
-
Istituto Giannina GasliniEubrainRecruiting
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedPreterm Birth | Cerebral Autoregulation | Premature Infant DiseaseItaly
-
Sun Yat-sen UniversityRecruitingPremature Infant DiseaseChina
-
Christiana Care Health ServicesCompletedInfant | Infant, Premature | Infant, Preterm | Infant, LateUnited States
Clinical Trials on Low CPAP Wean
-
Aarhus University HospitalCompletedRespiratory Distress Syndrome, Infant | PrematurityDenmark
-
University Hospital, BordeauxCompletedWeaning From Mechanical VentilationFrance
-
Baqiyatallah Medical Sciences UniversityCompletedRespiratory Failure
-
Maimonides Medical CenterCompletedRespiratory Distress SyndromeUnited States
-
International Centre for Diarrhoeal Disease Research...Armauer Hansen Research Institute (AHRI), EthiopiaCompleted
-
Hamilton Health Sciences CorporationTerminatedRespiratory Insufficiency of Prematurity
-
State Key Laboratory of Respiratory DiseaseCompletedSleep Apnea, Obstructive | Continuous Positive Airway Pressure | PolysomnographyChina
-
University of ZurichSwiss National Science FoundationCompleted
-
Chinese University of Hong KongCompleted
-
Ulysses Magalang MDTerminatedObstructive Sleep ApneaUnited States