Addition of Acetaminophen in Standard PDA Management

NCT ID: NCT04026464

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2021-05-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ibuprofen+Acetaminophen Group

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).

Group Type: ACTIVE_COMPARATOR

Intravenous Ibuprofen + Oral Acetaminophen

Intervention Type: 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 Group

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.

Group Type: PLACEBO_COMPARATOR

Intravenous Ibuprofen

Intervention Type: DRUG

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

Interventions

Intravenous Ibuprofen

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

Intervention Type: DRUG

Intravenous Ibuprofen + Oral Acetaminophen

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 28 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanket D Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

IRB201901829 -A

Identifier Type: -

Identifier Source: org_study_id