MedTrace Logo

Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

NCT01755728 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-08-06

No results posted yet for this study

Summary

There is a report that acetaminophen may have a role in pharmacological closure of PDA (Patent arterial duct) in preterm infants.

The investigators conducted this open label non randomized and non control study to try to support that report.

Conditions

  • PDA

Interventions

DRUG

Paracetamol

Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.

DRUG

Ibuprofen

Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature

PROCEDURE

Closure of PDA

Open surgery for closure of PDA

Sponsors & Collaborators

  • Hillel Yaffe Medical Center

    lead OTHER_GOV

Principal Investigators

  • Erez Nadir, MD · Hillel Yaffe medical center, Hadera, Israel

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Israel

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 NCT01755728 on ClinicalTrials.gov