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Acetaminophen vs Indomethacin in Treating hsPDA

NCT03537144 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-12-03

No results posted yet for this study

Summary

The purpose of this study is to see if acetaminophen (Tylenol) is as effective as indomethacin in closing patent ductus arteriosus in premature infants.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Indomethacin

IV indomethacin will be given every 12 hours for 3 doses. If \<48 hours old, 1st dose 0.2 mg/kg, 2nd dose 0.1 mg/kg, and 3rd dose 0.1mg/kg. If 2-7 days old, 1st dose 0.2 mg/kg, 2nd dose 0.2 mg/kg, and 3rd dose 0.2 mg/kg. If \>7 days old, 1st dose 0.2 mg/kg, 2nd dose 0.25 mg/kg, and 3rd dose 0.25 mg/kg.

DRUG

Acetaminophen

15mg/kg/dose every 6 hours for 12 doses

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03537144 on ClinicalTrials.gov