Skip to content

effect of prophylactic Acetaminophen in the prevention PDA (Patent Ductus Arteriosus) in premature neonates

Evaluating the effect of prophylactic Acetaminophen in the prevention PDA (Patent Ductus Arteriosus) in premature neonates: The randomized clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20081021001378N15
Enrollment
60
Registered
2023-04-29
Start date
2023-01-21
Completion date
Unknown
Last updated
2023-05-01

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

Interventions

Intervention 1: Intervention group: Premature newborn with a gestational age of less than 30 weeks will receive intravenous acetaminophen at 10 mg/kg every 6 hours for up to 3 days. Intervention 2: Co

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Consent to participate in the study Premature babies with a gestational age of less than 30 weeks Premature infants without evidence of patent ductus arteriosus

Exclusion criteria

Exclusion criteria: CHF Liver or kidney disease or cholestasis congenital heart disease PPHN Genetic disorders and congenital malformations Apgar score 5 minutes less than 5 PH <7.2 Septicemia Difference in pre-duct and post-duct oxygen saturation is more than 3%

Design outcomes

Primary

MeasureTime frame
Evaluating the effect of prophylactic acetaminophen intervention on the clinical manifestations of premature infants with a gestational age of less than 30 weeks. Timepoint: every 6 hours for three days. Method of measurement: The first dose will be prescribed after 12 hours of birth to provide enough time to examine the baby for underlying cardiac pathology, then every 6 hours for three days.

Secondary

MeasureTime frame
Sepsis. Timepoint: Every 6 hours for three days. Method of measurement: through laboratory tests.;Intraventricular hemorrhage. Timepoint: Every 6 hours for three days. Method of measurement: By sonography of the skull through the anterior fontanel.;Retinopathy of prematurity. Timepoint: Every 6 hours for three days. Method of measurement: Use of Ret Cam.;Bronchopulmonary dysplasia. Timepoint: Every 6 hours for three days. Method of measurement: Newborn age and oxygen need.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamira Alinezhad

Mashhad University of Medical Sciences

alinezhadms@mums.ac.ir+98 51 3851 2112

Outcome results

None listed

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