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Study comparing efficacy of two different method of surfactant therapy in preterm babies with respiratory distress syndrome

A Randomized Controlled Trial comparing surfactant administration using INSURE technique and the Minimally Invasive Surfactant Therapy via feeding tube in preterm neonates (28 to 34 weeks of gestation) with Respiratory Distress Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/017992
Enrollment
58
Registered
2019-03-08
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: J984- Other disorders of lung

Interventions

Intervention1: surfactant administration using minimally invasive surfactant therapy via feeding tube: preterm neonate 28 weeks to 34 weeks having RDS will receive surfactant via minimally invasive su

Sponsors

Goverment of West Bengal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All inborn neonates admitted in SSKM NICU with respiratory distress syndrome requiring CPAP or nasal intermittent positive pressure ventilation (NIPPV). 2. CPAP pressure of 5â??6 cm H2O and FiO2 more than 0.30. 3.NIPPV settins PEEP 5-6 cm H2O, PIP 15-18 cm H2O and FiO2 more than 0.30 4. Less than 6 hours of age. 5. Signed parental consent

Exclusion criteria

Exclusion criteria: 1. Previously intubated, or in imminent need of intubation because of respiratory distress, apnoea or persistent acidosis. 2. Congenital anomaly or condition that might adversely affect breathing. 3. Identifiable alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia). 4. Neonates with APGAR of 4 or less at 5 min after birth

Design outcomes

Primary

MeasureTime frame
patient requiring invasive mechanical ventilation within the first 72 hours after birthTimepoint: 72 hours—

Secondary

MeasureTime frame
1)Need for invasive mechanical ventilation at anytime and its duration. 2)Duration of non-invasive ventilation. 3)Need for repeated dose of surfactant. 4)Incidence of patent ductus arteriosus,necrotising enterocolitis,bronchopulmonary dysplasia,intraventricular hemorrhage grade more than 2 pneumothorax and mortalityTimepoint: Till the time of discharge or death—

Countries

India

Contacts

Public ContactDr Bhupendra kumar Gupta

IPGMER and SSKM hospital

drsmukherjee70@gmail.com9831485596

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 18, 2026