Can an inhaled medicine (budesonide) help newborn babies with breathing problems from meconium (first stool) aspiration recover faster and need breathing support for less time?

Effect of inhaled budesonide on duration of respiratory support in term neonates with meconium aspiration syndrome- A randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095777

Enrollment

100

Registered

2025-10-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: P240- Meconium aspiration

Interventions

Intervention1: Budesonide: Budesonide 0.5 mg diluted in 2.5 ml normal saline via nebulization, starting within 6 hours of life, second dose at 12 hours then every 12 hours for up to 3 days or until we

Eligibility

Inclusion criteria

Inclusion criteria: Term neonates (37 weeks gestation or more) with evidence of meconium aspiration presenting with moderate to severe respiratory distress (as defined by Downe s score equal to or greater than 4 or FiO2 requirement greater than 0.4 within 6 hours of life).

Exclusion criteria

Exclusion criteria: Neonates with major congenital anomalies (especially affecting respiratory and cardiovascular systems) Birth asphyxia with moderate to severe hypoxic-ischemic encephalopathy Neonates with congenital pneumonia/sepsis/at risk for early onset neonatal sepsis (EONS) Neonates requiring steroids for any other conditions

Design outcomes

Primary

Measure	Time frame
To compare the duration of respiratory support required by term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Up to 72 hours or until weaning from oxygen (whichever is earlier).	—

Secondary

Measure	Time frame
To determine the duration of hospitalization required by term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Till NICU stay;To determine the need for and duration of invasive mechanical ventilation by term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Till NICU stay;To determine the in-hospital mortality in term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Till NICU stay;To determine the incidence of hyperglycemic episodes, sepsis, hypertension and ventilator associated pneumonia in term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Till NICU stay	—

Measure

Time frame

To determine the duration of hospitalization required by term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Till NICU stay;To determine the need for and duration of invasive mechanical ventilation by term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Till NICU stay;To determine the in-hospital mortality in term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Till NICU stay;To determine the incidence of hyperglycemic episodes, sepsis, hypertension and ventilator associated pneumonia in term neonates with meconium aspiration having moderate to severe respiratory distress receiving inhaled budesonide versus placebo nebulization.Timepoint: Till NICU stay

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Countries

India

Contacts

Public ContactDr Pradeep Kumar Debata

Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

drpkdebata@gmail.com7291000664

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026