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Comparative Efficacy of Methods of giving Surfactant in Premature newborns

Less Invasive Surfactant Administration(LISA) versus Intubation Surfactant Administration Extubation(INSURE) in Management of Neonates with Respiratory Distress Syndrome - LISAINSURE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035649
Enrollment
100
Registered
2021-08-13
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(LISA): This procedure will be performed in the NICU after shifting the baby from the Labour Room employed as an Early Rescue Therapy (within 6 ho

Sponsors

PtBD UHSR PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants of 26-34 weeks of gestation who develop respiratory distress within 6 hours of birth and fio2 >0.3 on nCPAP of 5-6 cm of water

Exclusion criteria

Exclusion criteria: 1. Newborns with major congenital anomalies. 2. Newborns with perinatal asphyxia. 3. Newborns required intubation in the labour room. 4. Newborn delivered outside PGIMS Rohtak.

Design outcomes

Primary

MeasureTime frame
to measure the proportion of newborns Needing Invasive Mechanical Ventilation (IMV) in the first 72 hours of life.Timepoint: to measure the proportion of newborns Needing Invasive Mechanical Ventilation (IMV) in the first 72 hours of life.

Secondary

MeasureTime frame
neonates will be assessed on the basis of parameters like Bradycardia/Desaturation ,Need for intubation, Duration of hospital stay, Bronchopulmonary dysplasia (BPD),Intraventricular hemorrhage (IVH),Neonatal Necrotizing Enterocolitis (NNEC),MortalityTimepoint: till hospital stay

Countries

India

Contacts

Public ContactDr Kapil Bhalla

Pt.B.D. Sharma PGIMS Rohtak

kapil_bhalla@yahoo.com9813743565

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026