Health Condition 1: null- Preterm infant with gestation more than 27 weeks and birth weight more than 999 grams and respiratory distress within the first 6 hours of birth.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Preterm infant with gestation more than 29 weeks and birth weight more than 999 grams and respiratory distress within the first 6 hours of birth. Gestation assessed from the mothers LMP or from New Ballard score when LMP is unreliable or not available. Respiratory distress defined as presence of tachypnea, chest retraction and grunt (any of the two).
Exclusion criteria
Exclusion criteria: 1) Birth weight less than 1000 g 2) Gestational age less than28 weeks 3) Pneumothorax on Chest X-ray 4) Shock requiring inotropic support, multiorgan dysfunciton and encephalopathy 5) Abnormalities of upper and lower airways precluding use of CPAP or HHHFNC (Pierre-Robin, Treacher Collins, Goldenhar, choanal atresia, cleft lip/palate) 6) Serious abdominal, cardiac, or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, or diaphragmatic hernia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure of the support mode is the primary outcome of the study.Timepoint: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Bronchopulmonory dysplasiaTimepoint: 36 weeks of gestation;duration of noninvasive ventilation (either nCPAP or HHHFNC)Timepoint: Discharge;Duration of oxygen therapyTimepoint: Discharge;Duration of ventilationTimepoint: Discharge;Grade of nasal injuryTimepoint: discharge;Intraventricular hemorrhageTimepoint: Discharge;MortalityTimepoint: Discharge;Necrotising enterocolitisTimepoint: Discharge;Need of mechanical ventilation in first 7 daysTimepoint: 8th day;need of mechanical ventilation in the first 72 hoursTimepoint: 72 hours;Patent ductus arteriosusTimepoint: Discharge;Periventricular leucomalciaTimepoint: 40 weeks of gestation;Pulmonary air leaksTimepoint: Discharge;Retinopathy of prematurityTimepoint: Discharge;Supplemental oxygen at 28 days of lifeTimepoint: 28 days of life | — |
Countries
India
Contacts
Fernandez Hospital