Intratracheal Instillation of Pulmonary Surfactant Combined with Budesonide in Preterm Infants with RDS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220310005

Enrollment

120

Registered

2022-03-10

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Respiratory distress syndrome (RDS) requiring surfactant respiratory distress syndrome Bronchopulmonary dysplasia preterm infant

Interventions

Surfactant (Curosurf) 100-200 mg/kg via ETT or LISA technique,Surfactant (Curosurf) 100-200 mg/kg with budesonide 0.25 mg/kg via ETT or LISA technique

Active Comparator Drug,Active Comparator Drug

surfactant instillation,Surfactant with budesonide

Eligibility

Sex/Gender

All

Age

1 Hours to 12 Hours

Inclusion criteria

Inclusion criteria: Preterm infants born at less than 32 week of gestation or birth weight less than 1800 g who are diagnosed of RDS and require surfactant therapy within 12 after birth

Exclusion criteria

Exclusion criteria: 1. major congenital anomalies 2. parents do not give consent

Design outcomes

Primary

Measure	Time frame
Bronchopulmonary dysplasia (BPD) 36 week PMA BPD definition per NICHD 2018 and NIH 2011	—

Secondary

Measure	Time frame
ROP 40 wk PMA ROP classification,Duration of oxygen supplementation before discharge Durationof oxygen	—

Countries

Thailand

Contacts

Public ContactPracha Nuntnarumit

Ramathibodi Hospital

pracha.nun@mahidol.ac.th0819475906

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026