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Comparison of the dose effect of Oral Ibuprofen suspension for PDA Treatment in Premature Infants

Developmental pharmacokinetics and pharmacodynamics of chiral ibuprofen associated with the CYP2C8/9 gene polymorphism

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004559
Enrollment
Unknown
Registered
2014-04-15
Start date
2014-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

patent ductus arteriosus

Interventions

Standard group:First day 10mg/kg,then 5 mg/kg for last two days
High dose group:10mg/kg per day,for three days

Sponsors

Children’s Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. equal and less than 29 weeks' gestational age; 2. Diagnosis of PDA, according to echocardiography; 3. Written informed consent obtained from his/her parents; 4. Male and female, age of 2 to 7 days after birth.

Exclusion criteria

Exclusion criteria: 1. congenital anomalies; 2. severe infection; 3. intraventricular hemorrhage; 4. urine output below 1 ml/kg/h during the preceding 8 hours; 5. hyperbilirubinemia necessitating exchange transfusion; 6. serum creatinine concentration =1.6 mg/dL (140 µmol/L); 7. platelet count = 60,000 per cubic millimeter; 8. a tendency to bleed, as revealed by hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools, and oozing from puncture sites; 9. Infant included in other clinical trial.

Design outcomes

Primary

MeasureTime frame
patent ductus arteriosus closure rate;

Secondary

MeasureTime frame
Bleeding;

Countries

China

Contacts

Public ContactZhiping Li

Children's Hospital of Fudan University

zhipinglifudan@yeah.net+86 18017590744

Outcome results

None listed

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