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The efficacy of prophylactic treatment with oral acetaminophen for closure of patent ductus arteriosus in preterm infants

Investigation of efficacy rate of prophylactic treatment with oral paracetamol for closure of patent ductus arteriosus in preterm infants admitted in neonatal intensive care unit

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014090519050N1
Enrollment
30
Registered
2015-02-02
Start date
2012-03-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

patent ductus arteriosus. Congenital malformations of great arteries

Interventions

Intervention 1: Intervention group: Administration of 15mg/kg oral acetaminophen every 6 hours for 48 hours during first 24 hours after birth. Intervention 2: Control group: No intervention.
Treatment - Drugs
Intervention group: Administration of 15mg/kg oral acetaminophen every 6 hours for 48 hours during first 24 hours after birth
Control group: No intervention

Sponsors

Vice Chancellor for research of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Premature neonates born at or before 32 weeks of gestation with birth weight less than or equal to 1500 grams admitted in neonatal intensive care unit of Vali-e-Asr Hospital in 2012; parental consent for participating in this study. Exclusion criteria: Newborns with congenital heart defects that patency of ductus arteriosus is vital for them such as pulmonary atresia; congenital major anomalies or chromosomal abnormalities; maternal consumption of none steroidal anti-inflammatory drugs during pregnancy; newborns with hydrops fetalis or persistent pulmonary hypertension of the newborn; apgar score less than 5 at fifth minute after birth; appearance of patent of dutus arteriosus symptoms and requirement for treatment with Ibuprofen at any time; having vomiting or hematemesis during first 3 days after birth; neonates with glucose-6-phosphate dehydrogenase deficiency based on blood exam at beginning of neonatal admission

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Left Atrial to Aortic Ratio. Timepoint: 4-5 day of life. Method of measurement: Echocardiography.;Internal Ductal Diameter. Timepoint: 4-5 day of life. Method of measurement: Echocardiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Mohamad Reza Zarkesh

Tehran University of Medical Sciences

zarkesh@sina.tums.ac.ir+98 21 8889 7764

Outcome results

None listed

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