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A prospective randomized controlled trial of inhaled budesonide and beclomethasome for prevention and treatment of bronchopulmonary dysplasia in very preterm infants

A prospective randomized controlled trial of inhaled budesonide and beclomethasome for prevention and treatment of bronchopulmonary dysplasia in very preterm infants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091361
Enrollment
Unknown
Registered
2024-10-28
Start date
2024-10-28
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

bronchopulmonary dysplasia

Interventions

budesonide group :1 ml (0.5 mg) inhaled budesonide every 12 hours were given until the preterm infants no longer required respiratory support.
beclomethasome group:0.8 mg (2 ml) inhaled beclomethasome every 12 hours were given until the preterm infants no longer required respiratory support.
control group:1 ml inhaled normal saline every 12 hours were given until the preterm infants no longer required respiratory support.

Sponsors

Xuzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.1 Years

Inclusion criteria

Inclusion criteria: (1) gestational age 7 days; (2) Being admitted to hospital within 24 hours after birth and being diagnosed as RDS; (3) Non-invasive respiratory support is needed, and there are the following BPD risk factors: continuous FiO2>0.3, or gestational age < 28 weeks, or patent ductus arteriosus (hsPDA) with significant hemodynamic abnormality, or anemia requiring blood transfusion, or oligohydramnios, or intrauterine growth restriction, or risk score of BPD prediction model =-1(4) Obtain informed consent from parents.

Exclusion criteria

Exclusion criteria: (1) Severe congenital malformation (trisomy 21 syndrome, congenital diaphragmatic hernia, omphalocele, etc.); (2) Severe cyanotic congenital heart disease (such as transposition of great arteries, tetralogy of Fallot, etc.); (3) Congenital malformation of respiratory system (atresia of posterior nostril, cleft palate, tracheoesophageal fistula, etc.); (4) renal failure; (5) Vital signs are extremely unstable; (6) High frequency or constant frequency mechanical ventilation is still needed.

Design outcomes

Primary

MeasureTime frame
Respiratory support duration;

Secondary

MeasureTime frame
The incidence of BPD;FiO2 is reduced by more than 75% compared with the baseline;serum NTproBNP;

Countries

China

Contacts

Public ContactGao Xiangyu

Xuzhou Central Hospital

g.xy@163.com+86 189 5217 2025

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 6, 2026