A study on the benefits of nasal breathing support in premature babies
Phase 3
Completed
- Conditions
- Health Condition 1: J988- Other specified respiratory disordersHealth Condition 2: null- Premature neonates at birth
- Registration Number
- CTRI/2017/10/010001
- Lead Sponsor
- Surya Children Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
Inclusion Criteria
Preterm infants more than 28 weeks of gestation and/or more than 1 kg birth weight with respiratory distress and FiO2 requirement >30% within first 6 hours of birth.
Exclusion Criteria
1) Birth weight <1000 grams
2)Gestational age <28 weeks
3)Infant who already received surfactant
4)Pneumothorax on Chest X-ray
5)Shock requiring inotropic support, multi organ dysfunction and encephalopathy
6)Abnormalities of upper and lower airways precluding use of HHHFNC (Pierre-Robin, Treacher Collins, Goldenhar, choanal atresia, cleft lip/palate)
7)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 HHHFNC failure rate -composite outcome defined by the need of a) CPAP support b) surfactant treatment c) mechanical ventilationTimepoint: from birth until fifth day of postnatal age
- Secondary Outcome Measures
Name Time Method 1.Duration of respiratory support <br/ ><br>2.Duration of oxygen therapy. <br/ ><br>3.Need of CPAP <br/ ><br>4.Need of surfactant treatment <br/ ><br>5.Need of mechanical ventilation <br/ ><br>6.Mortality due to any cause. <br/ ><br>7.Pulmonary air leaks (pneumothorax, pulmonary interstitial emphysema) <br/ ><br>8. Nasal injuriesTimepoint: from admission until NICU discharge