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To compare two techniques of surfactant administration in immature lungs of preterm babies

Less invasive surfactant administration (LISA) versus INtubation SURfactant Extubation (INSURE) in preterm infants with respiratory distress syndrome: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018701
Enrollment
40
Registered
2019-04-24
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: J988- Other specified respiratory disorders

Interventions

Intervention1: Administration of surfactant: Administration of 100mg/kg surfactant in trachea using less invasive surfactant administration technique in patients who will meet the criteria using a 5 F

Sponsors

Prince pareek
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Spontaneously breathing preterm infants with RDS diagnosed within 24 hours of life from >=28 weeks 0 days to 36 weeks 6 daysâ?? gestational age with respiratory distress syndrome who will meet two or more criteria for surfactant therapy Those willing to participate in the study as consented by parents or relatives

Exclusion criteria

Exclusion criteria: Infants with anatomical abnormalities of upper airway or major congenital anomalies Infants with conditions where nasal non-invasive ventilation is contraindicated such as â?? congenital diaphragmatic hernia, trachea-oesophageal fistula, choanal atresia, cleft palate and poor respiratory efforts Infants whose FiO2 requirement is >=60% or hemodynamically unstable infants who require intubation and invasive ventilation for stabilization and therefore cannot be given non-invasive ventilation.

Design outcomes

Primary

MeasureTime frame
To compare the need for intubation and mechanical ventilation within 72 hours of birth (LISA versus INSURE) Timepoint: within 72 hours of birth

Secondary

MeasureTime frame
To evaluate and compare between the two groups: 1. Major complications 2. Duration of mechanical ventilation 3. Duration of non-invasive respiratory support 4. Need for repeated surfactant administration 5. Length of hospital stay 6. Adverse events during surfactant administration Timepoint: during hospital stay

Countries

India

Contacts

Public ContactPrince pareek

Bharati Vidyapeeth medical college, pune

drpradeepsuryawanshi@gmail.com9923540500

Outcome results

None listed

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