A study where premature babies presenting with breathlessness are randomly assigned three different methods of surfactant administration and then compared among each other.Surfactant is a chemical that prevents the collapse of tiny air sacs of the lungs.

A Randomised Control Trial comparing three different methods of surfactant administration in preterm neonates with Respiratory Distress Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042862

Enrollment

Registered

2022-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-30

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: Surfactant: The INSURE (Intubation Surfactant Extubation)Procedure. The infant will be first intubated through the mouth with an endotracheal tube appropriate to his weight and gestati

Eligibility

Inclusion criteria

Inclusion criteria: 1.Neonates admitted in Dr BC Roy PGIPS NICU & SNCU with respiratory distress syndrome requiring CPAP or nasal intermittent positive pressure ventilation (NIPPV). 2.Preterm neonates of 28 to 34 weeks of gestation. 2. CPAP pressure of 5â??8 cm H2O and FiO2 >= 0.30. 3..Age at admission :- 2 to 24 hours after birth 4.SNAPPE II Score of less than 38

Exclusion criteria

Exclusion criteria: 1. Previously intubated, or in imminent need of intubation because of respiratory distress, apnoea or persistent acidosis. 2. Congenital anomaly or condition that might adversely affect breathing. 3. Identifiable alternative cause for respiratory distress (e.g. congenital heart disease,pneumonia or pulmonary hypoplasia). 4.Severe perinatal asphyxia,Levene stage 3 and more.

Design outcomes

Secondary

Measure	Time frame
Duration of non-invasive ventilation.Timepoint: Hospital stay;Incidence of bronchopulmonary dysplasia and mortality. Timepoint: Hospital stay;Need for mechanical ventilation at any time and its duration.Timepoint: Hospital stay;Need for repeated dose of surfactant. Timepoint: Hospital stay	—

Primary

Measure	Time frame
Patients requiring mechanical ventilation within the first 72 hours after birthTimepoint: Patients requiring mechanical ventilation within the first 72 hours after birth	—

Countries

India

Contacts

Public ContactSubhasis Halder

Dr BC Roy Postgraduate Institute of Pediatric Sciences

saugata.dr@gmail.com9477036563

Outcome results

None listed

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