Steroid administration to lungs for better outcomes in immature babies

Intratracheal surfactant with or without budesonide for prevention of bronchopulmonary dysplasia in preterm neonates: A randomized double-blind controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087953

Enrollment

140

Registered

2025-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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: Surfactant with budesonide: Poractant alfa at 200 mg per kg (2.5 ml per kg) mixed with budesonide at 0.25 mg per kg (0.5 ml per kg). If repeat surfactant required, Poractant alfa at 100

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates less than 32 weeks with RDS within 48 hours of life meeting the criteria for surfactant therapy (FiO2 requirement equal to or more than 30% on CPAP or MV, or need for MV in neonates less than 30 weeks irrespective of FiO2 requirement)

Exclusion criteria

Exclusion criteria: Neonates who are not actively resuscitated at birth as per parental wishes, Neonates who receive surfactant prior to study enrolment, Neonates with major congenital malformations, and Non-availability of parental consent

Design outcomes

Primary

Measure	Time frame
Composite outcome of death or bronchopulmonary dysplasiaTimepoint: at 36 weeks postmenstrual age (PMA)	—

Secondary

Measure	Time frame
Mortality, incidence of BPD & its severity at 36 weeks PMA, incidence of other morbidities during hospital stay such as intraventricular hemorrhage (IVH) grade 3 or 4, retinopathy of prematurity (ROP) requiring treatment, necrotizing enterocolitis (NEC) stage 2 or more, cystic periventricular leukomalacia (PVL), hemodynamically significant patent ductus arteriosus (hsPDA), neonatal sepsis (culture proven or clinical), air leak syndrome, spontaneous intestinal perforation, & pulmonary hemorrhage, & duration of respiratory support & hospital stayTimepoint: during hospital stay;Incidence of adverse events like gastrointestinal hemorrhage, pulmonary hemorrhage, hyperglycemia (RBS more than 180 mg/dL), hypertension requiring treatment, late-onset sepsis and oral candidiasisTimepoint: within 14 days of intervention	—

Measure

Time frame

Mortality, incidence of BPD & its severity at 36 weeks PMA, incidence of other morbidities during hospital stay such as intraventricular hemorrhage (IVH) grade 3 or 4, retinopathy of prematurity (ROP) requiring treatment, necrotizing enterocolitis (NEC) stage 2 or more, cystic periventricular leukomalacia (PVL), hemodynamically significant patent ductus arteriosus (hsPDA), neonatal sepsis (culture proven or clinical), air leak syndrome, spontaneous intestinal perforation, & pulmonary hemorrhage, & duration of respiratory support & hospital stayTimepoint: during hospital stay;Incidence of adverse events like gastrointestinal hemorrhage, pulmonary hemorrhage, hyperglycemia (RBS more than 180 mg/dL), hypertension requiring treatment, late-onset sepsis and oral candidiasisTimepoint: within 14 days of intervention

—

Countries

India

Contacts

Public ContactMayank Priyadarshi

AIIMS Rishikesh

mayank.neonat@aiimsrishikesh.edu.in09968856843

Outcome results

None listed

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