A clinical trial comparing two different nasal flow supports in preterm infants from birth

Efficacy of HFNC vs CPAP as a primary respiratory support in preterm neonates more than 30 weeks GA requiring early rescue surfactant:a non-inferiority randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026199

Enrollment

210

Registered

2020-06-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: HHHFNC Group: Humidified Nasal high flow (6-8) litres/min initiated within 6 hours of postnatal age Control Intervention1: CPAP Group: Continuous positive airway pressure (bubble CPAP)

Eligibility

Inclusion criteria

Inclusion criteria: Premature infants with gestational age greater than 30 weeks with respiratory distress from birth and requiring early-dose surfactant therapy within 6 hours of life.

Exclusion criteria

Exclusion criteria: 1. Infants requiring extensive resuscitation at birth 2.Pneumothorax 3.Shock requiring inotropic support 4.Multi organ dysfunction 5.Encephalopathy 6.Serious congenital anomalies generally considered to be incompatible with life 7. Any serious abdominal, cardiac, or respiratory malformations 8. Repeated apneas

Design outcomes

Primary

Measure	Time frame
Treatment failure (requirement of higher respiratory support)Timepoint: First week of postnatal age	—

Secondary

Measure	Time frame
All cause mortalityTimepoint: During NICU stay;Bronchopulmonary Dysplasia at 36 weeksTimepoint: At 36 weeks corrected gestational age;Culture-Positive SepsisTimepoint: During NICU stay;Duration of hospital stayTimepoint: At time of discharge;Duration of invasive ventilationTimepoint: During NICU stay;Duration of non-invasive ventilation (days)Timepoint: During NICU stay;Duration of oxygen therapyTimepoint: During NICU stay;Duration of respiratory supportTimepoint: During NICU stay;Hemodynamically-significant patent ductus arteriosusTimepoint: During NICU stay;Intraventricular Hemorrhage - grade 3 or 4Timepoint: During NICU stay;Long-term neurological outcome of the infantTimepoint: At 18 and 24 months corrected gestational age;Maximum FiO2 requiredTimepoint: During NICU stay;Nasal InjuryTimepoint: During NICU stay;Necrotizing Enterocolitis (Bells Criteria Stage II or more)Timepoint: During NICU stay;Need for 2nd dose surfactantTimepoint: During NICU stay;Need for ventilationTimepoint: During NICU stay;Pulmonary air leaks (pneumothorax, pulmonary interstitial emphysema)Timepoint: During NICU stay;Retinopathy of Prematurity (requiring treatment)Timepoint: During NICU stay or 3 months post-discharge;Time to reach full enteral feeds and full oral feedsTimepoint: During NICU stay	—

Measure

Time frame

All cause mortalityTimepoint: During NICU stay;Bronchopulmonary Dysplasia at 36 weeksTimepoint: At 36 weeks corrected gestational age;Culture-Positive SepsisTimepoint: During NICU stay;Duration of hospital stayTimepoint: At time of discharge;Duration of invasive ventilationTimepoint: During NICU stay;Duration of non-invasive ventilation (days)Timepoint: During NICU stay;Duration of oxygen therapyTimepoint: During NICU stay;Duration of respiratory supportTimepoint: During NICU stay;Hemodynamically-significant patent ductus arteriosusTimepoint: During NICU stay;Intraventricular Hemorrhage - grade 3 or 4Timepoint: During NICU stay;Long-term neurological outcome of the infantTimepoint: At 18 and 24 months corrected gestational age;Maximum FiO2 requiredTimepoint: During NICU stay;Nasal InjuryTimepoint: During NICU stay;Necrotizing Enterocolitis (Bells Criteria Stage II or more)Timepoint: During NICU stay;Need for 2nd dose surfactantTimepoint: During NICU stay;Need for ventilationTimepoint: During NICU stay;Pulmonary air leaks (pneumothorax, pulmonary interstitial emphysema)Timepoint: During NICU stay;Retinopathy of Prematurity (requiring treatment)Timepoint: During NICU stay or 3 months post-discharge;Time to reach full enteral feeds and full oral feedsTimepoint: During NICU stay

—

Countries

India

Contacts

Public ContactMansi Shah

Surya Hospital

doctorhbk@gmail.com9820457078

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026