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INTRA-AMNIOTIC SURFACTANT USE FOR PREVENTING RESPIRATORY DISTRESS SYNDROME IN PRETERM BIRTH

INTRA-AMNIOTIC INSTILLATION OF SURFACTANT FOR PROPHYLAXIS OF NEONATAL RESPIRATORY DISTRESS SYNDROME IN PRETERM BIRTH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/12/006399
Enrollment
40
Registered
2015-12-01
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: null- Pregnant women between 28-34 weeks of gestational age, before preterm birth

Interventions

Intervention1: natural bovine surfactant: 3 ml of natural bovine surfactant given. Each ml contains 27 ml phospholipids and 176-500 mcg of surfactant associated proteins SP-B and SP-C Control Interven

Sponsors

Project under thesis at All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women at 28-34 weeks of gestational age, in preterm labour or before preterm caesarean section

Exclusion criteria

Exclusion criteria: Preterm premature rupture of membranes, chorioamnionitis, congenital fetal malformations, positive foam stability test (for lung maturity) in amniotic fluid

Design outcomes

Primary

MeasureTime frame
Incidence of respiratory distress syndrome (RDS),severity of RDS, need of postnatal intra-tracheal surfactantTimepoint: Outcome was assessed at the time of delivery and till discharge of baby from nursery

Secondary

MeasureTime frame
APGAR score (at 1 and 5 minutes after birth), foam stability test of gastric lavage, FiO2 requirement of CPAP and its duration, need of mechanical ventilation and its duration, length of hospital stayTimepoint: once

Countries

India

Contacts

Public ContactNutan Agarwal

All India Institute of Medical Sciences, New Delhi

shique_88@yahoo.co.in9599691966

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 1, 2026