Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

November 1, 2024

Study Completion Date

December 30, 2024

Conditions
Patent Ductus Arteriosus
Interventions
DRUG

Paracetamol

"All cases will be randomized simply by opaque closed envelop and treated with either rectal or intravenous paracetamol according to the following doses.~* Rectal dose~ * Rectal paracetamol at a dose of 25 mg/kg body weight with started and then continued at a dose of 15 mg/kg body weight every 8 hours for 3 days (ten doses in total) in neonates weighing more than 1000 gm.11~ * The patient's weight is less than 1000 gm, the initial dose was 15 mg/kg body weight, and the suspense doses are 7.5 mg/kg body weight every 8 hours for 3 days (10 doses in total).11~* Intravenous dose~ * Intravenous paracetamol dose 15 mg/kg body weight every 6 hours for 3 days (12 doses in total).12~ * After the 3-day follow up echocardiogram will be done.12 This will be the end of randomization for the purpose of the study."

All Listed Sponsors
collaborator

Assiut University

OTHER

lead

Soha mahmoud Hussien mahdy

OTHER

NCT06256211 - Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates | Biotech Hunter | Biotech Hunter