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Comparison of Oral Paracetamol versus Ibuprofen in Premature Infants<1500g with Patent Ductus Arteriosus: A Randomized Controlled Triall

Comparison of Oral Paracetamol versus Ibuprofen in Premature Infants <1500g with Patent Ductus Arteriosus: A Randomized Controlled Triall

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003912
Enrollment
Unknown
Registered
2013-12-07
Start date
2013-10-21
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 in preterm infants

Interventions

paracetamol:Oral paracetamol
ibuprofen:Oral ibuprofen

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Birth weight <1500g; 2. postnatal age within 14 days; 3. Continuous positive airway pressure with FiO2 more than 25%; 4. Echocardiographic criteria for PDA included an increased left atrial diameter compared with the aortic root (left-atrium- to-aortic-root ratio higher than 1.4), OR visualization of the ductus (more than 1.5 mm), AND evidence of left-to-right blood flow through the open duct.

Exclusion criteria

Exclusion criteria: 1. Congenital heart disease which required PDA to maintain blood flow; 2. hocardiographic evidence of right-to-left blood flow through the open duct; 3. life-threatening infection; 4. recent (within the previous 24 h) intraventricular hemorrhage, grade 3-4; 5. urine output =133 umol/L; 7. platelet count of <=50*10^9/L; 8. hyperbilirubinemia requiring exchange transfusion; 9. bleeding tendency(defined by the presence of blood in endotracheal aspirate, gastric aspirate, stools or urines, and/or by oozing from puncture sites); 10. active necrotizing enterocolitis (NEC) and/or intestinal perforation; 11. liver disfunction.

Design outcomes

Primary

MeasureTime frame
The rate of ductal closure;

Secondary

MeasureTime frame
side effect;

Countries

China

Contacts

Public ContactWu Hui

Department of Neonatology, The First Hospital of Jilin University

wuhui97@126.com+86 431 88783771

Outcome results

None listed

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