Addition of Acetaminophen in Standard PDA Management

NCT04026464 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: IRB201901829 -A
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

• Percentage of infants with PDA closure.

  Percentage of patients who demonstrated PDA closure.

  During hospitalization, up to 10 days

Study Arms (2)

Ibuprofen+Acetaminophen Group

ACTIVE COMPARATOR

Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen \[160 mg/5ml concentration\] every 6 hours for a total of 12 doses).

Drug: Intravenous Ibuprofen + Oral Acetaminophen

Ibuprofen Group

PLACEBO COMPARATOR

Infants with PDA randomized to the control mono therapy group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) alone.

Drug: Intravenous Ibuprofen

Interventions

Intravenous Ibuprofen DRUG

The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.

Ibuprofen Group

Intravenous Ibuprofen + Oral Acetaminophen DRUG

The combined treatment group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently and will in addition receive 15 mg/kg oral acetaminophen \[160 mg/5ml concentration\] every 6 hours for a total of 12 doses.

Ibuprofen+Acetaminophen Group

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
• 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)
• Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
• Echocardiographic criteria:
• Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery \> 0.5

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sanket D Shah, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 19, 2019
• Study Start: April 1, 2021
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share