Addition of Acetaminophen in Standard PDA Management

Sponsor

University of Florida (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04026464

Collaborator

(none)

Enrollment

Arms

1.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Drug: Intravenous Ibuprofen Drug: Intravenous Ibuprofen + Oral Acetaminophen	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

May 12, 2021

Actual Study Completion Date :

May 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	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.
Placebo Comparator: 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.	Drug: Intravenous Ibuprofen The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.

Arm

Intervention/Treatment

Active Comparator: 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).

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.

Placebo Comparator: 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.

Drug: Intravenous Ibuprofen

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

Outcome Measures

Primary Outcome Measures

Percentage of infants with PDA closure. [During hospitalization, up to 10 days]
Percentage of patients who demonstrated PDA closure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Weeks to 28 Weeks

Sexes Eligible for Study:

All

Accepts 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:

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Sanket D Shah, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT04026464

Other Study ID Numbers:

IRB201901829 -A

First Posted:

Jul 19, 2019

Last Update Posted:

Jun 24, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ductus Arteriosus, Patent

Acetaminophen

Ibuprofen

Study Results

No Results Posted as of Jun 24, 2021