Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Primary Purpose
Transient Tachypnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prophylactic CPAP Administration
Sponsored by
About this trial
This is an interventional prevention trial for Transient Tachypnea focused on measuring Transient Tachypnea of the Newborn, Elective Cesarean section, Late preterm, CPAP, Delivery Room
Eligibility Criteria
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.
Sites / Locations
- New York Hospital Queens
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prophylactic CPAP intervention
No Intervention
Arm Description
Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff)
Provision of standard care in the Delivery Room
Outcomes
Primary Outcome Measures
Measure of incidence of TTN
Need for admissions to NICU secondary to TTN
Secondary Outcome Measures
levels of plasma brain natriuretic peptide compared
Duration of tachypnea
Duration of oxygen therapy
Length of hospital (NICU) stay
Full Information
NCT ID
NCT01082900
First Posted
March 8, 2010
Last Updated
October 5, 2015
Sponsor
New York Hospital Queens
1. Study Identification
Unique Protocol Identification Number
NCT01082900
Brief Title
Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Hospital Queens
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at delivery, and mode of delivery are considered risk factors for TTN. The investigators hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot study to evaluate the prophylactic administration of CPAP in the Delivery Room towards prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a randomized control trial after obtaining informed consents from the parents of eligible infants. Infants will be randomized to receive either experimental treatment (prophylactic CPAP) or standardized care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea
Keywords
Transient Tachypnea of the Newborn, Elective Cesarean section, Late preterm, CPAP, Delivery Room
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic CPAP intervention
Arm Type
Experimental
Arm Description
Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff)
Arm Title
No Intervention
Arm Type
Active Comparator
Arm Description
Provision of standard care in the Delivery Room
Intervention Type
Other
Intervention Name(s)
Prophylactic CPAP Administration
Intervention Description
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
Primary Outcome Measure Information:
Title
Measure of incidence of TTN
Time Frame
24 hours
Title
Need for admissions to NICU secondary to TTN
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
levels of plasma brain natriuretic peptide compared
Description
Duration of tachypnea
Duration of oxygen therapy
Length of hospital (NICU) stay
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Minutes
Maximum Age & Unit of Time
30 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinchi Srinivasan, MD
Organizational Affiliation
New York Hospital Queens
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Hospital Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
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