A multicenter, single-arm, open-label clinical study of ibuprofen trometamol injection in the treatment of patent ductus arteriosus in premature neonates

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052063

Enrollment

Unknown

Registered

2021-10-16

Start date

2021-01-22

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

Patent ductus arteriosus

Interventions

Intervention group:Intravenous injection of inbuprofen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Premature newborns with gestational aged 1.4; or flow reversal in the descending aorta; or ductus arteriosus diameter >= 1.5 mm); clinical manifestations: (1) Systolic or continuous murmur heard at the left sternal border; (2) Increased precordial pulsation; (3) Corrigans pulse or widened pulse pressure (> 25 mmHg); (4) Heart rate > 160/min at rest; (5) Increased need for respiratory support; 4. If premature newborns are one of multiple births, select one who meet the inclusion criteria; 5. Legal guardians agree to participate and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have a history of allergy to the active substance or any excipients of this product; 2. Life-threatening infections, such as sepsis, septic shock; 3. Grade III and above intracranial hemorrhage or advanced intracranial hemorrhage, active gastrointestinal bleeding; 4. Thrombocytopenia (= 1.8 mg/dL, ALT and AST greater than 2 times the normal value), including severe hyperbilirubinemia requiring exchange transfusion,oliguria or anuria (urine volume < 0.6 mL/kg/hr); 7. Ductus arteriosus dependent systemic/pulmonary circulation congenital heart disease; 8. Ongoing treatment of persistent pulmonary hypertension; 9. Known or suspected necrotizing enterocolitis; 10. Major congenital malformations and/or chromosomal abnormalities; 11. NSAIDs are used prenatally in pregnant women within 72 hours prior to delivery; 12. Premature infants have used NSAIDs or glucocorticoids after birth; 13. Expected survival of preterm infants < 48 hours in the opinion of the investigator; 14. Premature newborns are one of multiple births, and other sibling has been enrolled; 15. Other situations not suitable for participation in the investigator's opinion

Design outcomes

Primary

Measure	Time frame
Closure rate of ductus arteriosus in all neonates;Proportion of neonates receiving the second course of treatment;Proportion of neonates requiring surgery or other treatment;	—

Countries

China

Contacts

Public ContactMu Dezhi

West China Second Hospital, Sichuan University

mudz@scu.edu.cn+86 28 85501313

Outcome results

None listed

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