Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants
NCT ID: NCT01721629
Last Updated: 2017-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
380 participants
INTERVENTIONAL
2012-09-30
2017-04-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
NCT03292562
Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
NCT02064712
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
NCT02126501
E-23596 - Use of NCPAP Cycling to Wean Preterm Infants
NCT02114112
Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial
NCT07009366
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sudden wean of nasal CPAP
The CPAP is taken off at the morning ward round. If the discontinuation of the CPAP fails according to prespecified failure criteria, CPAP is recommenced and continued for at least 24 hours. Then a new evaluation takes place and if the infant again meets the inclusion criteria another attempt of sudden wean can be undertaken. Infants are considered successfully weaned if they are off CPAP for three days.
Sudden wean of nasal CPAP
Gradual wean of nasal CPAP pressure
The reduction of the CPAP pressure begins at the morning ward round and the pressure is reduced in steps with 1 cmH2O maximum once a day. Each time the pressure is to be reduced the infant needs to be evaluated according to the inclusion criteria and only if these are still met, will the pressure be reduced. When a CPAP pressure at 4 cmH2O is reached the infant is treated with this pressure for 24 hours and then the CPAP is discontinued. Infants are considered successfully weaned if they are off CPAP for three days.
Gradual wean of nasal CPAP
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sudden wean of nasal CPAP
Gradual wean of nasal CPAP
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current gestational age \> 28+6 weeks
* Nasal CPAP for \> 24 hours
* Nasal CPAP pressure \< 8 cmH2O
* Oxygen requirement \< 30% and not increasing
* Respiratory rate \< 70 per minute
* Less than 3 episodes of oxygen saturation \< 70% or a heart rate \< 70 beat per minute in the preceding 24 hours
* Tolerates time off CPAP during cares (up to 15 minutes)
Exclusion Criteria
* Surgical procedures performed on the gastrointestinal tract
* Known or suspected to have congenital neuromuscular disease
* Known or suspected syndrome
6 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aarhus University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christina Friis Jensen
MD, Ph.D. student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christina F Jensen, MD
Role: PRINCIPAL_INVESTIGATOR
The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
Tine B Henriksen, Professor
Role: STUDY_DIRECTOR
Department of Paediatrics, Aarhus University Hospital
Kirsten Wisborg, Centre Director, DMSc
Role: STUDY_CHAIR
Aarhus University Hospital, Head-Neuro Centre
Finn Ebbesen, Professor
Role: STUDY_CHAIR
Department of Paediatrics, Aalborg University Hospital
Anna S Sørensen, MD, Ph.D.
Role: STUDY_CHAIR
The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aalborg University Hospital, Department of Pediatrics
Aalborg, DK, Denmark
Aarhus University Hospital, Department of Pediatrics
Aarhus, DK, Denmark
Herning Hospital, Department of Pediatrics
Herning, DK, Denmark
Viborg Hospital, Department of Pediatrics
Viborg, DK, Denmark
Vendsyssel Hospital, Department of Pediatrics
Hjørring, , Denmark
Randers Hospital, Department of Pediatrics
Randers, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jensen CF, Sellmer A, Ebbesen F, Cipliene R, Johansen A, Hansen RM, Nielsen JP, Nikitina OH, Petersen JP, Henriksen TB. Sudden vs Pressure Wean From Nasal Continuous Positive Airway Pressure in Infants Born Before 32 Weeks of Gestation: A Randomized Clinical Trial. JAMA Pediatr. 2018 Sep 1;172(9):824-831. doi: 10.1001/jamapediatrics.2018.2074.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AAUH190280
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.