Delivery Room CPAP in Extremely Low Birth Weight Infants
NCT ID: NCT01223274
Last Updated: 2017-09-26
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
PHASE1/PHASE2
104 participants
INTERVENTIONAL
2002-07-31
2003-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants \<28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
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.
CPAP/PEEP Intervention
Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.
CPAP/PEEP
Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.
Control
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
Standard management practices
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CPAP/PEEP
Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.
Standard management practices
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \<28 weeks gestational age by best obstetric estimate before delivery
* Requiring resuscitation
Exclusion Criteria
* Decision made not to provide full resuscitation
10 Minutes
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Center for Research Resources (NCRR)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of California - San Diego
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neil N. Finer, MD
Role: STUDY_DIRECTOR
University of California, San Diego
Avroy A. Fanaroff, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies & Children's Hospital
Waldemar A. Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Edward F. Donovan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Charles R. Bauer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
W. Kenneth Poole, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California at San Diego
San Diego, California, United States
University of Miami
Miami, Florida, United States
RTI International
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
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.
Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394.
Related Links
Access external resources that provide additional context or updates about the study.
NICHD Neonatal Research Network
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NICHD-NRN-0028
Identifier Type: -
Identifier Source: org_study_id