A Study on Improving the Clinical Prognosis of High risk congenital heart disease under 3 months of age with Pulmonary Surfactants

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500104855

Enrollment

Unknown

Registered

2025-06-24

Start date

2023-08-28

Completion date

Unknown

Last updated

2025-06-30

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

Conditions

Congenital heart disease

Interventions

Pulmonary surfactant group:Pulmonary surfactant administration (15mg/kg,1ml)within 24 hours after surgery for congenital heart disease

control group:Administer 1ml of physiological saline within 24 hours after surgery for congenital heart disease

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: (1) Age: = 90 minutes; (5) after surgery, PaO2/FiO2 <= 300

Exclusion criteria

Exclusion criteria: (1) Residual cardiac malformations with hemodynamic significance; (2) Palliative surgery; (3) Patients with postoperative cardiac dysfunction (LVEF = 1 week) or even ECMO support due to various reasons; (4) Concomitant congenital airway malformations (such as airway stenosis, presence of bridging bronchi, and bronchial dysplasia); (5) Patients with congenital malformations of the brain, gastrointestinal tract, liver and kidney (such as hydrocephalus, hydronephrosis, or gallbladder deficiency).

Design outcomes

Primary

Measure	Time frame
Postoperative ventilator application time;	—

Secondary

Measure	Time frame
Postoperative ICU time;mortality;	—

Countries

China

Contacts

Public ContactRongyuan Zhang

Fuwai Hospital, Chinese Academy of Medical Sciences

fwpicu@163.com+86 10 8839 8101

Outcome results

None listed

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