Skip to content

Comparision of surfactant and surfactant with budesonide to reduce the incidence of chronic lung disease in a very preterm newborns - a randomised control trial

Does surfactant mixed with budesonide in comparison with surfactant, reduce the incidence of BPD in very preterms- A Randomised control trial - NIL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065406
Enrollment
120
Registered
2024-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P369- Bacterial sepsis of newborn, unspecified Health Condition 2: P27- Chronic respiratory disease originating in the perinatal period Health Condition 3: P520- Intraventricular (nontraumatic) hemorrhage, grade 1, of newborn Health Condition 4: P521- Intraventricular (nontraumatic) hemorrhage, grade 2, of newborn Health Condition 5: P522- Intraventricular (nontraumatic) hemorrhage, grade 3 and grade 4, of newborn Health Condition 6: Q250- Patent ductus arteriosus Health Cond

Interventions

Intervention1: Budesonide mixed with Surfactant: Dose: 1.Bovine Surfactant (Neosurf,Cipla) 5ml/kg 2.Budesonide 0.25mg/kg Frequency: 1st dose will be given within the first 6 hours of birth and second

Sponsors

Shaik Mohammed Munthakheem
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn babies less than 30 weeks, weigth less than 1500 grams, age less than 48 hours, requiring invasive or non invasive respiratory support, clinical decision to give surfactant and consent obtained

Exclusion criteria

Exclusion criteria: Infants with major congenital anomalies, birth asphyxia (Apgar score less than 4 at 5 minutes after birth), who had prolonged resuscitation, and lethal cardiopulmonary disorder were excluded.

Design outcomes

Primary

MeasureTime frame
Death or BPD or BPD and DeathTimepoint: Death or discharge

Secondary

MeasureTime frame
NEC,IVH,ROP,Sepsis,PDA, Use of post natal steriodsTimepoint: Death or discharge

Countries

India

Contacts

Public ContactShaik Mohammed Munthakheem

Government medical college

deshmukhls@yahoo.com9822478275

Outcome results

None listed

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