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BOVINE VS PORCINE SURFACTANT REPLACEMENT THERAPY

Comparison of efficacy between Bovine Lipid Extract Surfactant(BLES) and Poractant-a in Respiratory Distress Syndrome among preterm infants(28-34 weeks gestational age) by Less Invasive Surfactant Administration(LISA) technique: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061733
Enrollment
100
Registered
2024-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J984- Other disorders of lung

Interventions

Intervention1: BOVINE LIPID EXTRACT SURFACTANT: Bovine Lipid Extract Surfactant(Neosurf®) at a dose of 135mg/kg( 5ml/kg) Control Intervention1: PORCINE DERIVED SURFACTANT: Poractant-a (Curosurf®) at a

Sponsors

IPGMER AND SSKM HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Intramural Preterm babies with gestational age between 28 to 34 weeks diagnosed with RDS and eligible for surfactant administration by LISA technique will be enrolled in this study

Exclusion criteria

Exclusion criteria: • Baby with major congenital anomaly • Perinatal asphyxia • Intubated at the delivery room • An alternative cause of respiratory distress • Any baby requiring mechanical ventilation and surfactant administration

Design outcomes

Primary

MeasureTime frame
Requirement for intubationTimepoint: WITHIN 72 HOURS OF LIFE

Secondary

MeasureTime frame
•Complications occurring during the procedure •Need for the second dose of Surfactant •Duration of respiratory support •Pulmonary haemorrhage •Pulmonary air leak syndromes •Hemodynamically significant PDA requiring treatment •Grade 3 & grade 4 IVH •Periventricular Leukomalacia •ROP requiring Laser treatment •NEC stage 2 & above •Duration of hospital stay •Bronchopulmonary dysplasia(BPD) •Death before hospital discharge Timepoint: TILL THE HOSPITAL DISCHARGE

Countries

India

Contacts

Public ContactDR ASHADUR ZAMAL

IPGMER AND SSKM HOSPITAL

bijansaha18@gmail.com9051389120

Outcome results

None listed

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