Comparing the effect of budesonide as adjuvant with surfactant with surfactant alone in preterm neonates by single blinded randomised trial

The Effect Of Intratracheal Administration Of Surfactant And Budesonide Combination In Comparison To Surfactant Alone In Preterm Neonates With Respiratory Distress Syndrome (RDS)- A Randomized Single Blinded Clinical Trail - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092674

Enrollment

110

Registered

2025-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: J989- Respiratory disorder, unspecified

Interventions

Intervention1: Intratracheal administration of bovine lipid surfactant (100mg/kg/dose) along with intratracheal administration of budesonide(0.25mg/kg) single STAT dose by intubation surfactant and ex

Eligibility

Inclusion criteria

Inclusion criteria: Infants with gestational age between 24 weeks to 34 weeks requiring surfactant therapy

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies 2. Major cardiac anomalies 3. Chorioamnionitis

Design outcomes

Primary

Measure	Time frame
1. Respiratory support and its duration 2. Duration of hospital stay 3. Mortality 4. Chronic lung disease of prematurity 5. Need for 2nd dose of surfactantTimepoint: 1. Respiratory support and its duration till the time of discharge 2. Duration of hospital stay till the time of discharge 3. Mortality 4. Chronic lung disease of prematurity 5. Need for 2nd dose of surfactant 6-12 hours after surfactant administration	—

Measure

Time frame

1. Respiratory support and its duration 2. Duration of hospital stay 3. Mortality 4. Chronic lung disease of prematurity 5. Need for 2nd dose of surfactantTimepoint: 1. Respiratory support and its duration till the time of discharge 2. Duration of hospital stay till the time of discharge 3. Mortality 4. Chronic lung disease of prematurity 5. Need for 2nd dose of surfactant 6-12 hours after surfactant administration

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Secondary

Measure	Time frame
1. Necrotizing Enterocolitis 2. Intraventricular Haemorrhage 3. Retinopathy of Prematurity 4. Patent Ductus ArteriosusTimepoint: 1. Necrotizing Enterocolitis after 1 to 2 weeks (mean-12 days). 2. Intraventicular hemorrhage on day 3, day 7. 3. Retinopathy of Prematurity-screening will be done at 2-3weeks for neonates born less than or equal to 28 weeks. Neonates born more than 28 weeks will be screened before discharged or at 4 weeks of postnatal age. 4. Patent Ductus Arteriosus screened on day 3.	—

Measure

Time frame

1. Necrotizing Enterocolitis 2. Intraventricular Haemorrhage 3. Retinopathy of Prematurity 4. Patent Ductus ArteriosusTimepoint: 1. Necrotizing Enterocolitis after 1 to 2 weeks (mean-12 days). 2. Intraventicular hemorrhage on day 3, day 7. 3. Retinopathy of Prematurity-screening will be done at 2-3weeks for neonates born less than or equal to 28 weeks. Neonates born more than 28 weeks will be screened before discharged or at 4 weeks of postnatal age. 4. Patent Ductus Arteriosus screened on day 3.

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Countries

India

Contacts

Public ContactSrusti Shetty

Sri Devaraj Urs Academy of Higher Education and Research

drjamesdaniel83@gmail.com9886314477

Outcome results

None listed

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