Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Preterm infants between 30 to 34+6 weeks of gestation who develop mild to moderate respiratory distress between 4 to 48 hours of birth, requiring FiO2 0.3 to 0.60 to maintain SpO2 88 to 95 percent on nCPAP of 5to 6 cm of H2O and signed the parental consent.
Exclusion criteria
Exclusion criteria: Previous intubation or Surfactant therapy. Apgar score of greater than or equal to 3 at 5 min. Pneumothorax prior to enrolment. Severe RDS indicated by FiO2 greater than 0.60. Newborns with major congenital anomalies (major malformations involving craniofacial, Cardiac or thoracic). Newborns with perinatal asphyxia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for mechanical ventilation within 72 hours of surfactant administrationTimepoint: Within 3 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospital stay Intraventricular haemorrhage (IVH) Neonatal Necrotizing Enterocolitis Mortality Timepoint: Untill discharge or death. | — |
Countries
India
Contacts
Pt. Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana