Breathing stabilization in small babies at the time of birth
Not Applicable
Completed
- Conditions
- Health Condition 1: P039- Newborn affected by complication of labor and delivery, unspecified
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
Inclusion Criteria
1. Spontaneously breathing inborn neonates
of gestational age between 28+0 weeks to 36+6
weeks having a birth weight >= 800 g.
2. Presence of any one sign of respiratory
distress, such as,
i. tachypnea (respiratory rate >60/min)
ii. subcostal and/or intercostal retractions
iii. grunting
iv. nasal flaring
2. FiO2 requirement more than 0.3 to maintain
minute specific target oxygen saturations as
advised by the neonatal resuscitation
guidelines of the American Academy of
Pediatrics.
Exclusion Criteria
1. Requirement of intubation at birth as per
neonatal resuscitation guidelines of the
American Academy of Pediatrics guidelines
2. Major congenital anomalies
3. Inability to attain parental consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment failure defined as FiO2 requirement of 0.4 or greater, arterial blood gas pH 7.2 or less with PaCO2 more than 50 mm Hg, multiple episodes of apnea requiring positive pressure ventilation and need for urgent intubation and mechanical ventilation despite providing maximal available supportTimepoint: 24 hours after randomization
- Secondary Outcome Measures
Name Time Method 1.Time to treatment failure <br/ ><br>2.Need for surfactant <br/ ><br>3.Duration of respiratory support and supplemental oxygen <br/ ><br>4.Age of starting feeds and time to achieve full feeds <br/ ><br>5.Duration of hospital stay <br/ ><br>6.Weight at discharge <br/ ><br>7.Adverse events including death,nasal trauma, air leak syndrome, shock, patent ductus arteriosus, sepsis, necrotising enterocolitis, intestinal perforation, bronchopulmonary dysplasia, retinopathy of prematurity, <br/ ><br>intraventricular hemorrhage, periventricular leukomalacia <br/ ><br>Timepoint: At discharge from hospital and till 1 year at different time points