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Surfactant (drug to open collapsed lungs) with budesonide (drug to reduce inflammation) in reducing duration of use of ventilator and improving outcome in very small preterm babies : Open labelled randomized controlled trial

Surfactant with budesonide in reducing duration of respiratory support and respiratory morbidity in preterm neonates less than 32 weeks: Open labelled randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026502
Enrollment
116
Registered
2020-07-10
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: P22- Respiratory distress of newborn

Interventions

Intervention1: Surfactant with budesonide: surfactant in a dose of 100mg/kg/dose mixed with budesonide in a dose of 0.25mg/kg/dose is administered intratracheally to the patient Control Intervention1:

Sponsors

Munmun Sahney
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Receiving mechanical ventilation via an endotracheal tube, or infants receiving non-invasive respiratory support including continuous positive airway pressure (CPAP), non-invasive intermittent positive pressure ventilation (NIPPV) or nasal high flow (HF), and a clinical decision to treat the infant with exogenous surfactant.

Exclusion criteria

Exclusion criteria: 1. Infant is considered non-viable (less than 23 weeks) or is not going to be admitted to the neonatal intensive care unit (NICU) 2. Known or suspected major congenital anomaly that are likely to affect respiratory status (upper airway obstruction, severe pulmonary hypoplasia following oligohydramnios, congenital lung malformation, and major congenital heart disease)

Design outcomes

Primary

MeasureTime frame
1. Total duration of respiratory support and supplemental oxygen therapy (Mechanical ventilator, nasal CPAP, HFNC)Timepoint: At discharge and 28 days of life

Secondary

MeasureTime frame
1. Death prior to hospital discharge, 2. Length of hospital stay, 3. BPD, 4. Other major neonatal morbidities (intraventricular haemorrhage, hyperglycemia, gastrointestinal bleed, periventricular leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, spontaneous intestinal perforation, pneumothorax, PDA treated pharmacologically or with surgery, sepsis) Timepoint: At discharge and 28 days of life

Countries

India

Contacts

Public ContactMunmun Sahney

Dr Mehtas Multispeciality hospital

drlakshmi2008@gmail.com9840211742

Outcome results

None listed

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