Transient Tachypnea of the Newborn
Conditions
Brief summary
Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.
Detailed description
The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.
Interventions
DEVICENeopuff
* Group I neonates (Experimental group) includes 30 newborns showing signs of TTN who will receive administration of CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand). * Group II neonates (Control group) includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Days
Healthy volunteers
No
Inclusion criteria
* Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age). * Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth. * Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.
Exclusion criteria
* Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization. * Presence of any other cause of respiratory distress, eg. * congenital malformations affecting the cardiorespiratory system , * chromosomal aberrations, * depression at birth (Apgar score at 5 minutes of \< 7 or umbilical artery pH of \< 7.10), * fetal hydrops, * persistent pulmonary hypertension, * and meconium aspiration syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for admissions to NICU secondary to TTN | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Duration of tachypnea. | until discharge |
| Duration and type of oxygen therapy. | ntil discharge |
| Antibiotic treatment. | until discharge |
| Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours]. | 24 hours |
| Length of hospital (NICU) stay | until discharge |
| Death | until discharge |
| Incidence of pulmonary air leaks | ntil discharge |
Outcome results
None listed