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Comparison of two methods of surfactant treatment of respiratory distress syndrome in preterm babies

Comparison of two different modalities of delivery of surfactant in preterm babies admitted with RDS in NICU

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/12/022356
Enrollment
162
Registered
2019-12-13
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: Delivery of bovine surfactant by two methods in babies diagnosed of RDS: INSURE method- Intubate,surfactant administration & extubate MIST method- Minimally invasive surfactant administ

Sponsors

Saikat Patra
Lead Sponsor
Swati Manerkar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates with gestation age <=32 weeks & who were diagnosed with RDS

Exclusion criteria

Exclusion criteria: Major congenital anomalies Babies requiring intubation in delivery room Outborn babies Apgar =16

Design outcomes

Primary

MeasureTime frame
Incidence of combined outcome of mortality or chronic lung disease(CLD)Timepoint: at time of discharge from unit or death—

Secondary

MeasureTime frame
post procedure apnea need for intubation & ventilation in the first 72hrs of life number of days of invasive ventilation support number of days of oxygen support number of days of hospitalization rates of pneumothorax early onset sepsis patent ductus arteriosus (PDA) requiring medical or surgical treatment intraventricular hemorrhage retinopathy of prematurity necrotizing enterocolitisTimepoint: at time of discharge from unit or death—

Countries

India

Contacts

Public ContactSwati Manerkar

Lokmanya Tilak Municipal Medical College

drswatimanerkar@gmail.com9769997968

Outcome results

None listed

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