Health Condition 1: P039- Newborn affected by complication of labor and delivery, unspecified
Conditions
Interventions
Intervention1: Humidified high flow nasal cannula (Optiflow Junior, Fisher & Paykel Healthcare): Humidified high flow nasal cannula will be started at an initial flow-rate of 4-6 L/min and FiO2 to mai
Sponsors
All India Institutute of Medical Sciences Rishikesh
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1.Time to treatment failure 2.Need for surfactant 3.Duration of respiratory support and supplemental oxygen 4.Age of starting feeds and time to achieve full feeds 5.Duration of hospital stay 6.Weight at discharge 7.Adverse events including death,nasal trauma, air leak syndrome, shock, patent ductus arteriosus, sepsis, necrotising enterocolitis, intestinal perforation, bronchopulmonary dysplasia, retinopathy of prematurity, intraventricular hemorrhage, periventricular leukomalacia Timepoint: At discharge from hospital and till 1 year at different time points | — |
Countries
India
Contacts
Public ContactSriparna Basu
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed