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The rescue treatment after expectant management of hemodynamically significant patent ductus arteriosus for preterm infants: A randomized controlled trial

The rescue treatment after expectant management of hemodynamically significant patent ductus arteriosus for preterm infants: A randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056444
Enrollment
Unknown
Registered
2022-02-06
Start date
2022-02-07
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Patent ductus arteriosus in preterm infants

Interventions

Acetaminophen group:Acetaminophen
High dose ibuprofen group:High dose ibuprofen

Sponsors

Xuzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Gestational age = 1.5 mm, left atrial inner diameter / aortic root >= 1.5, diastolic descending aortic reflux; (3) It has one of the following clinical manifestations: systolic murmur, increased precordial pulsation, water rushing pulse, increased pulse pressure difference and deterioration of respiratory condition.

Exclusion criteria

Exclusion criteria: 1. Children with extremely unstable vital signs, congenital heart disease relying on arterial catheter opening, persistent pulmonary hypertension, etc.; 2. The clinical data are unreliable or incomplete, as well as children whose parents refuse diagnosis and treatment, discharge automatically, death and so on; 3. The family members of the child refused to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Serum cystatin C;

Secondary

MeasureTime frame
PDA closure rate after conservative management;Incidence of adverse reactions after rescue treatment;

Countries

China

Contacts

Public ContactGao Xiangyu

Xuzhou Central Hospital

g.xy@163.com+86 18952172025

Outcome results

None listed

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