- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01082900
Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Prophylactic CPAP/PEEP in Delivery Room (DR) Resuscitation, Effects on Natriuretic Peptide in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Flushing, New York, United States, 11355
- New York Hospital Queens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor.
- Late preterm infants (34 1/7 to 36 6/7 weeks gestational age)
Exclusion Criteria:
- Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization
- Need for use of PPV for perinatal depression or other indications
Presence of any of the following
- congenital malformations (diagnosed prenatally)
- chromosomal anomalies (diagnosed prenatally)
- congenital heart disease diagnosed by fetal echocardiography.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Prophylactic CPAP intervention
Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff)
|
EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff) CONTROL GROUP: Provision of standard care in the Delivery Room |
ACTIVE_COMPARATOR: No Intervention
Provision of standard care in the Delivery Room
|
EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff) CONTROL GROUP: Provision of standard care in the Delivery Room |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Need for admissions to NICU secondary to TTN
Time Frame: 24 hours
|
24 hours
|
Measure of incidence of TTN
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
levels of plasma brain natriuretic peptide compared
Time Frame: 24 hours
|
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pinchi Srinivasan, MD, New York Hospital Queens
Study record dates
Study Major Dates
Study Start
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 (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5720108
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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