Intratracheal Budesonide With Surfactant for Prevention of Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants

Preventing Bronchopulmonary Dysplasia In Extremely Low Birth Weight Infants With Intratracheal Budesonide Combined With Surfactant: A Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/111257

Enrollment

106

Registered

2026-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: P271- Bronchopulmonary dysplasia originating in the perinatal period

Interventions

Intervention1: Intratracheal surfactant plus nebulised Budesonide suspension: Respiratory distress syndrome requiring surfactant will be diagnosed clinically based on the need for fractional inspired

Eligibility

Inclusion criteria

Inclusion criteria: Inborn Birth weight less than 1000 grams Respiratory distress syndrome requiring surfactant.

Exclusion criteria

Exclusion criteria: Major congenital anomalies Known/suspected chromosomal anomalies Severe perinatal asphyxia Previously received surfactant Outborn babies Refused consent

Design outcomes

Primary

Measure	Time frame
Incidence of bronchopulmonary dysplasia free survival at 44 weeks post menstrual ageTimepoint: Incidence of bronchopulmonary dysplasia free survival at 44 weeks post menstrual age	—

Secondary

Measure	Time frame
Duration of respiratory support at 44 weeks post menstrual age Incidence of NEC( Modified Bell Staging 2 or more) Pulmonary air leak including pulmonary interstitial emphysema(PIE),pneumomediastinum & pneumothorax ( confirmed on roentgenogram) Intraventricular hemorrhage(IVH), grade 3 & above on cranial ultrasound Incidence of culture positive neonatal sepsis Hemodynamically significant patent ductus arteriosus requiring treatment Retinopathy of prematurity Total duration of NICU stay Total duration of hospitalisation Death ( all causes) before discharge Timepoint: At the time of 44 weeks post menstrual age	—

Measure

Time frame

Duration of respiratory support at 44 weeks post menstrual age Incidence of NEC( Modified Bell Staging 2 or more) Pulmonary air leak including pulmonary interstitial emphysema(PIE),pneumomediastinum & pneumothorax ( confirmed on roentgenogram) Intraventricular hemorrhage(IVH), grade 3 & above on cranial ultrasound Incidence of culture positive neonatal sepsis Hemodynamically significant patent ductus arteriosus requiring treatment Retinopathy of prematurity Total duration of NICU stay Total duration of hospitalisation Death ( all causes) before discharge Timepoint: At the time of 44 weeks post menstrual age

—

Countries

India

Contacts

Public ContactDr Madhurima Ganguly

IPGMER AND SSKM HOSPITAL

ratansarmistha2011@gmail.com9433702671

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026