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Multicenter study of pulmonary surfactant combined with budesonide in prevention and treatment of bronchopulmonary dysplasia

Multicenter study of pulmonary surfactant combined with budesonide in prevention and treatment of bronchopulmonary dysplasia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048967
Enrollment
Unknown
Registered
2021-07-19
Start date
2021-07-31
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

Bronchopulmonary Dysplasia (BPD)

Interventions

Observation Group 1:Calf Pulmonary Surfactant 100mg/kg was intratracheal dripping, and budesonide suspension 400ug was atomized and inhaled at Q12h until extubation
Observation Group 2:Calf Pulmonary Surfactant 100mg/kg was intratracheal dripping, and budesonide suspension 200ug was atomized and inhaled at Q12h until extubation
Observation Group 3:Calf Pulmonary Surfactant 100mg/kg and budesonide suspension 250 ug/kg was intratracheal dripping, and budesonide suspension 200ug was atomized and inhaled at Q12h until extubation
Control Group:Calf Pulmonary Surfactant 100mg/kg was intratracheal dripping

Sponsors

Maternal and Child Health Hospital of Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 2 Years

Inclusion criteria

Inclusion criteria: 1. The gestational age <30 weeks or birth weight <1500 g; 2. The diagnosis of respiratory distress syndrome (RDS) after birth requires treatment with surfactant (Calf Pulmonary Surfactant); 3. Clinical dyspnea occurred within 12 hours after birth and mechanical ventilation was required; 4. Obtain informed consent from the parent or guardian of the neonate.

Exclusion criteria

Exclusion criteria: Severe congenital deformity or severe congenital heart and lung disease.

Design outcomes

Primary

MeasureTime frame
Incidence and severity of BPD;Physical development index and intellectual development index;Inflammatory factors in bronchoalveolar lavage fluid (IL-1, IL-6, IL-8, TNF-alpha, NF-kB);

Secondary

MeasureTime frame
The incidence of complications in premature infants;

Countries

China

Contacts

Public ContactXia Shiwen

Maternal and Child Health Hospital of Hubei Province

shiwenxia66@163.com+86 18971025669

Outcome results

None listed

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