Less invasive surfactant administration vs Intubation, surfactant and extubation in preterm neonates with respiratory distress syndrome

To compare the need for mechanical ventilation between administration of surfactant by LISA and INSURE technique - LISA Vs INSURE

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032720

Enrollment

250

Registered

2021-04-09

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: Less invasive surfactant administration method: Less invasive surfactant administration (LISA) involves insertion of a thin catheter into the trachea of a spontaneously breathing infant

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age 2. Diagnosis of RDS based on clinical signs and confirmation by chest x ray findings and need for NIV support ( FiO2 >30 %; PEEP >6 H2O) to maintain saturation between 90% and 95% in the first 6 hours of life

Exclusion criteria

Exclusion criteria: 1. Severe RDS been treated with endotracheal intubation 2. Major congenital malformation or complex CHD 3. Pulmonary haemorrhage 4. Cardiopulmonary failure 5. Congenital genetic metabolic disease 6. Gestational age less than 28 weeks 7. Transferred out of NICU with surgical treatment or other intervention

Design outcomes

Primary

Measure	Time frame
Need for mechanical ventilation in first 72 hours Timepoint: First 72 hours after surfactant administration	—

Secondary

Measure	Time frame
Apnea, bradycardia, or desaturation Timepoint: During surfactant administration;Duration of hospital stayTimepoint: During hospitalisation;Duration of oxygen requirementTimepoint: During hospitalisation;Early onset sepsisTimepoint: 72 hours;MortalityTimepoint: During hospitalisation;PneumothoraxTimepoint: During hospitalisation;Requirement of repeat dose of surfactant Timepoint: 6 hours after surfactant administration	—

Measure

Time frame

Apnea, bradycardia, or desaturation Timepoint: During surfactant administration;Duration of hospital stayTimepoint: During hospitalisation;Duration of oxygen requirementTimepoint: During hospitalisation;Early onset sepsisTimepoint: 72 hours;MortalityTimepoint: During hospitalisation;PneumothoraxTimepoint: During hospitalisation;Requirement of repeat dose of surfactant Timepoint: 6 hours after surfactant administration

—

Countries

India

Contacts

Public ContactDr Ashu Jamwal

Department of Paediatrics

ashu.sainik@gmail.com9419148113

Outcome results

None listed

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