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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic CPAP intervention | Experimental | Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff) |
|
| No Intervention | Active Comparator | Provision of standard care in the Delivery Room |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic CPAP Administration | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of incidence of TTN | 24 hours | |
| Need for admissions to NICU secondary to TTN | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| levels of plasma brain natriuretic peptide compared |
| 24 hours |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Pinchi Srinivasan, MD | New York Hospital Queens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Hospital Queens | Flushing | New York | 11355 | United States |
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| ID | Term |
|---|---|
| D059245 | Transient Tachypnea of the Newborn |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D059246 | Tachypnea |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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