Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial

Study Overview
=================
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.

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

Conditions
-----------------
Transient Tachypnea

Intervention / Treatment
-----------------
* Other: Prophylactic CPAP Administration


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Minutes
Maximum Age: 30 Minutes

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic CPAP intervention<br>Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff) | Other: Prophylactic CPAP Administration<br>* 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<br>|
| Active Comparator: No Intervention<br>Provision of standard care in the Delivery Room | Other: Prophylactic CPAP Administration<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of incidence of TTN |  | 24 hours | 
| Need for admissions to NICU secondary to TTN |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of plasma brain natriuretic peptide compared | Duration of tachypnea Duration of oxygen therapy Length of hospital (NICU) stay | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transient Tachypnea of the Newborn, Elective Cesarean section, Late preterm, CPAP, Delivery Room