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Comparison of oral ibuprofen versus acetaminophen in premature infants with patent ductus arteriosus

Comparison of oral ibuprofen versus acetaminophen in premature infants with patent ductus arteriosus (PDA) in kosar Hospital-Iran

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015120425357N1
Enrollment
106
Registered
2015-12-20
Start date
2014-06-22
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. Patent ductus arteriosus

Interventions

Intervention 1: The first group of patients treated with ibuprofen at a dose of 10 mg/kg/stat and then 5 mg/kg/12h to two doses. Intervention 2: The second group of patients treated with acetaminophen
Treatment - Drugs
The first group of patients treated with ibuprofen at a dose of 10 mg/kg/stat and then 5 mg/kg/12h to two doses.
The second group of patients treated with acetaminophen for two days at a dose of 15 mg/kg/6h (8 doses).

Sponsors

Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 14 Days

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Gestational age less than or equal to 34 weeks; Birth elapsed time less than or equal to 14 days; PDA diagnosis based on echocardiography findings. Exclusion Criteria: Any type of congenital heart disease is to keep the blood flow needed PDA; Life-threatening infections; Grade 3-4 intraventricular hemorrhage (within recent 24 hours); Urinary output less than 1mg/kg/h in last 8 hours; Serum creatinine level higher than 88 µmol/L; platelet counts less than 109×50 per liter; Hyperbilirobinemia requiring blood transfusions; Active necrotizing enterocolitis or bowel perforation; Liver dysfunction; Gastrointestinal bleeding; Retinopathy; Bronchopulmonary dysplasia; Lack of parental consent.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Heart murmur. Timepoint: Before intervention - three days after the intervention. Method of measurement: Auscultation - Echocardiography.

Secondary

MeasureTime frame
Bleeding Including the gastrointestinal tract, urinary tract and respiratory tract. Timepoint: During the intervention. Method of measurement: Clinical observation and tests such as analysis of urine and faeces.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTahereh Jangjoo Pirbazari

Qazvin University of Medical Sciences

t.jangjoo@qums.ac.ir-tahereh.jangjoo.p@gmail.com-esmail.jangjoo@gmail.com+98 28 3333 4808

Outcome results

None listed

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