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Effect of adding steroids to routine treatment in managing preterm babies with respiratory distress

Effect of intratracheal budesonide and surfactant on the ventilatory requirements in preterm neonates born between 25 weeks and 31 weeks of gestation â?? A double blinded randomized controlled study - NeoCISS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030392
Enrollment
92
Registered
2021-01-11
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: Combination of Budesonide and pulmonary surfactant: Intratracheal administration of budesonide (250 mcg/kg/dose) and surfactant (Survanta 4ml/kg) in babies fulfilling the criteria for s

Sponsors

Susmitha Tangirala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All preterm neonates born between 25 weeks and 31 weeks of gestation and requiring surfactant therapy will be included in the study

Exclusion criteria

Exclusion criteria: Neonates born with major congenital malformations that are incompatible with life will be excluded.

Design outcomes

Primary

MeasureTime frame
Requirement of respiratory support on day 7 of life in intervention and control groupsTimepoint: Day 7—

Secondary

MeasureTime frame
Culture positive sepsisTimepoint: until 36 weeks post menstrual age;Incidence of BPD or death at 36 weeks post menstrual ageTimepoint: 36 weeks post menstrual age;Intraventricular hemorrhage (grade III and more on Volpeâ??s classification)Timepoint: until first 2 weeks of life;Necrotising enterocolitis (stage 2 or more on Modified Bellâ??s staging)Timepoint: until first 4 weeks of life;Need for continued non-invasive ventilatory support by day 14 and day 28 of lifeTimepoint: day 14 and day 28 of life;Patent ductus arteriosus (PDA) requiring medical or surgical managementTimepoint: until first 3 weeks of life;Retinopathy of prematurity and requiring treatmentTimepoint: until 36 weeks post menstrual age—

Countries

India

Contacts

Public ContactDr Prakash A

Sri Ramachandra Institute of Higher Education and Research

draprakash1@gmail.com9791181566

Outcome results

None listed

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