Skip to content

A study on the benefits of nasal breathing support in premature babies

Efficacy & safety of standard Vs high flow rates of Nasal High Flow therapy in very preterm neonates- A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010001
Enrollment
200
Registered
2017-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: J988- Other specified respiratory disorders Health Condition 2: null- Premature neonates at birth

Interventions

Intervention1: 8-10 litres/min of nasal high flow therapy: 8-10 litres/min of heated humidified nasal high flow thearpy initiated in preterm infants with respiratory distress within 6 hrs of birth Con

Sponsors

Surya Children Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1) Birth weight 2) Gestational age 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Duration of respiratory support 2. Duration of oxygen therapy. 3. Need of CPAP 4. Need of surfactant treatment 5. Need of mechanical ventilation 6. Mortality due to any cause. 7. Pulmonary air leaks (pneumothorax, pulmonary interstitial emphysema) 8. Nasal injuriesTimepoint: from admission until NICU discharge

Countries

India

Contacts

Public ContactDr Bhawandeep Garg

Surya Childrens Hospital

bhawandeepgarg@gmail.com7738617972

Outcome results

None listed

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