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

Oral acetaminophen versus paracetamol in the preterm with persistent patent ductus arteriosus admitted to the neonatal intensive care unit of Imam Reza (AS) Hospital in Mashhad

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140907019076N3

Enrollment

100

Registered

2021-09-29

Start date

2020-08-22

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Patent ductus arteriosus. Patent ductus arteriosus neonates

Interventions

Intervention 1: Intervention group: ?15 mg / kg prakid acetaminophen drop (100 mg/ml) will prescribed every 6 hours for 3 days and 15 mg / kg intravenous ?acetaminophen every 6 hours for 3 days.?. Int

Eligibility

Sex/Gender

All

Age

1 Days to 30 Days

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtiyeh Eshkil

Mashhad University of Medical Sciences

eshkils941@mums.ac.ir38521121

Outcome results

None listed

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