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Comparison of methods of surfactant administration in premature infants.

Surfactant administration using Less invasive surfactant administration versus Enhanced Intubate Surfactant Extubate method in preterm infants. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055841
Enrollment
100
Registered
2023-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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: LISA (Less Invasive Surfactant Administration): Direct laryngoscopy will be performed and surfcath semi stiff LISA catheter will be inserted with black tip mark beyond vocal cord. (Hoba

Sponsors

Government medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Spontaneously breathing preterm neonates between 26 and 35 weeks of gestation who will require surfactant therapy for Respiratory Distress Syndrome.

Exclusion criteria

Exclusion criteria: Babies who had a major congenital anomaly, with hemodynamic instability requiring inotropic support prior to randomization, had suffered severe asphyxia (Apgar score less than 4 at 5 minutes and/or requiring positive pressure ventilation for more than 2 minutes) and those who were already intubated at the time of first surfactant dose.

Design outcomes

Primary

MeasureTime frame
Need of invasive ventilationTimepoint: Within 72 hours of surfactant administration

Secondary

MeasureTime frame
Adverse events (apnea, desaturation, bradycardia) Timepoint: At time of surfactant administration;Death before dischargeTimepoint: Before discharge;Duration of hospitalizationTimepoint: Before discharge;Duration of procedure Timepoint: At time of surfactant administration;Proportion of babies with BPD, ROP (needing treatment), NEC (greater than Stage 2a), IVH (greater than grade2)Timepoint: Before discharge;Requirement of invasive ventilation after 72 hoursTimepoint: Before discharge;Requirement of repeat surfactant dosage Timepoint: Within 24 hours;Total duration of respiratory support & invasive ventilationTimepoint: Before discharge

Countries

India

Contacts

Public ContactDr Palak khera

Government medical college and hospital, chandigarh

dr.sukshamj@gmail.com9988901596

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 15, 2026