Oral acetaminophen versus paracetamol in the preterm with persistent patent ductus arteriosus

Phase 3

• Conditions: Patent ductus arteriosus.; Patent ductus arteriosus neonates; Q25.0

• Registration Number: IRCT20140907019076N3
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Preterm newborns with persistent patent ductus arteriosus by echocardiography pediatric cardiologist
Parents' consent
Gestational age less than 37weeks
Birth weight less than 2000 gr

Exclusion Criteria

Congenital heart disease that requires Patent ductus arteriosus (PDA)
Liver diseases
Active necrotizing enterocolitis or intestinal perforation
Gastrointestinal bleeding

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Persistent patent ductus arteriosus. Timepoint: Echocardiography before treatment and after treatment for 24 hours. Method of measurement: IPX7 echocardiography device with CA1-7AD curve probe is used for echocardiography.

Secondary Outcome Measures

Name	Time	Method
Arterial duct closure time. Timepoint: After the end of treatment. Method of measurement: Echocardiography.;Number of courses of treatment. Timepoint: After diagnosis, it is treated for three days and if necessary, a three-day period is repeated. Method of measurement: Echocardiography.;Medication side effects. Timepoint: Throughout the treatment and after the end of treatment. Method of measurement: Clinical signs and lab tests.;Comorbidities and mortality. Timepoint: During treatment. Method of measurement: Clinical signs and lab tests.