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Use of physiologically based pharmacokinetic to assess precision medication of oral ibuprofen for patent ductus arteriosus closure in preterm infants

Ibuprofen pharmacokinetics in preterm infants with patent ductus arteriosus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067714
Enrollment
Unknown
Registered
2023-01-19
Start date
2023-01-19
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Patent ductus arteriosus

Interventions

Test group:oral ibuprofen

Sponsors

the Affiliated Yongchuan Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 1 Years

Inclusion criteria

Inclusion criteria: 1. Preterm neonates <= 35 completed weeks of gestation at birth with echocardiographic confirmation of a hemodynamically significant PDA (hsPDA) after 2 days of life; 2. Obtained the informed consent of parents; 3. All infants has an indwelling vascular catheter; 4. All infants has an stomach tube.

Exclusion criteria

Exclusion criteria: 1. Neonates with being allergic to COX inhibitor; 2. Hyperbilirubinemia; 3. Infection or suspected infection; 4. Intraventricular haemorrhage or gastrointestinal bleeding; 5. Coagulation or thrombocytopenia; 6. Necrotizing enterocolitis; 7. Renal dysfunction (serum creatinine > 1 mg/dL), oliguria (< 1 mL/kg/h); 8. Ductus arteriosus dependent congenital heart disease (pulmonary atresia, tetralogy of Fallot or coarctation aorta).

Design outcomes

Primary

MeasureTime frame
Plasma concentration of ibuprofen;Area under the curve (AUC) from zero to infinity;Area under the curve (AUC) 0-t;Gestational age, Gender, Birth weight;Indexes such as urine volume, liver and kidney function before and after administration;Diameter of arterial duct, LA/AO, LVEF, Pulmonary artery flow rate and other indicators before and after administration;Maximum peak concentration of ibupeofen;

Countries

China

Contacts

Public ContactFang Gong

the Affiliated Yongchuan Hospital of Chongqing Medical University

gflinda@163.com+86 13594016166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 20, 2026