Addition of Acetaminophen in Standard PDA Management

Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial

NCT04026464•University of Florida

View on ClinicalTrials.gov

Summary

Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight \< 1000 grams
•Hemodynamically significant PDA as defined by any of the following:
•1. Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
•2. Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
•3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
•Echocardiographic criteria:
•1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery \> 0.5

Exclusion Criteria

•No enteral feedings
•PDA-dependent congenital heart disease
•Prior treatment with prophylactic indomethacin
•Prior PDA treatment with any medications
•Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
•Abnormal liver enzymes (ALT \> 60 IU/L and AST \> 60 IU/L)
•Platelets count \< 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
•Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
•Prior enrollment to other interventional clinical study where PDA is an outcome variable

Key Dates

Start Date

April 1, 2021

Primary Completion Date

May 12, 2021

Completion Date

May 12, 2021

Last Updated

June 24, 2021

Conditions

Patent Ductus Arteriosus

Interventions

Intravenous Ibuprofen

DRUG

Intravenous Ibuprofen + Oral Acetaminophen

DRUG

PDA for Kidneys Study

NCT06658496

Patent Ductus ArteriosusCongenital Heart Disease

View study

RECRUITINGEARLY_PHASE1

The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

NCT06298344

Congenital Heart DiseaseThiamine Deficiency+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Addition of Acetaminophen in Standard PDA Management

Inclusion Criteria

Exclusion Criteria

PDA for Kidneys Study

The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates

Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems

Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

Canadian National PDA Treatment Study