Can Heated Humidified High Flow Nasal Cannula (HHHFNC) replace Nasal CPAP (nCPAP) for respiratory support in preterm infants with respiratory distress
- Conditions
- 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.
- Registration Number
- CTRI/2015/08/006108
- Lead Sponsor
- Fernandez hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 218
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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Failure of the support mode is the primary outcome of the study.Timepoint: 72 hours
- Secondary Outcome Measures
Name Time Method 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