IV Acetaminophen and Patent Ductus Arteriosus

NCT ID: NCT03008876

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-06-30

Brief Summary

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This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.

Detailed Description

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Conditions

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Patent Ductus Arteriosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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acetaminophen

Group of patients randomized to receive acetaminophen to treat their PDA

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

infants receive acetaminophen for treatment of their PDA

ibuprofen

Group of patients randomized to receive ibuprofen to treat their PDA

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

infants receive ibuprofen, standard of care in our unit, for treatment of a PDA

Interventions

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Acetaminophen

infants receive acetaminophen for treatment of their PDA

Intervention Type DRUG

Ibuprofen

infants receive ibuprofen, standard of care in our unit, for treatment of a PDA

Intervention Type DRUG

Other Intervention Names

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tylenol

Eligibility Criteria

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Inclusion Criteria

* preterm infants 23-30 weeks gestation,
* PDA requiring treatment

Exclusion Criteria

* infection,
* congenital heart disease,
* genetic syndrome,
* NEC,
* pulmonary hypertension,
* hydrops,
* intestinal perforation,
* grade 3 or 4 IVH,
* serum creatinine \>1.5,
* previous treatment with a COX inhibitor.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albany Medical College

OTHER

Sponsor Role lead

Responsible Party

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Kate Tauber

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Albany Medical Center Neonatal Intesive Care Unit

Albany, New York, United States

Site Status

Countries

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United States

Other Identifiers

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4683

Identifier Type: -

Identifier Source: org_study_id

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