Addition of Acetaminophen in Standard PDA Management

Phase 2

Withdrawn

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: Intravenous Ibuprofen + Oral Acetaminophen; Drug: Intravenous Ibuprofen

• Registration Number: NCT04026464
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Study Start: 2021-04
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen+Acetaminophen Group	Intravenous Ibuprofen + Oral Acetaminophen	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).
Ibuprofen Group	Intravenous Ibuprofen	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.

Primary Outcome Measures

Name	Time	Method
Percentage of infants with PDA closure.	During hospitalization, up to 10 days	Percentage of patients who demonstrated PDA closure.