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Alternative Paracetamol Treatments for the Neonate With a hsPDA

NCT03604796 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-07-30

No results posted yet for this study

Summary

Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.

Conditions

  • Ductus Arteriosus, Patent

Interventions

DRUG

Rectal Solution

Rectal acetaminophen at 15 mg/kg x 4/day for three days

DRUG

Intravenous Infusion

Loading dose of 15 mg/kg IV acetaminophen followed by a continuous infusion at a rate of 2.5 mg/kg/hr for 72 hours

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Cathy Hammerman, MD · Shaare Zedek Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2021-09-30
Completion
2022-01-31

Countries

  • Israel

Study Locations

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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 NCT03604796 on ClinicalTrials.gov