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Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates

NCT06256211 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-13

No results posted yet for this study

Summary

To compare the effectiveness of rectal vs. intravenous paracetamol in the medical treatment of significant PDA in neonates.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Paracetamol

All cases will be randomized simply by opaque closed envelop and treated with either rectal or intravenous paracetamol according to the following doses. * Rectal dose * Rectal paracetamol at a dose of 25 mg/kg body weight with started and then continued at a dose of 15 mg/kg body weight every 8 hours for 3 days (ten doses in total) in neonates weighing more than 1000 gm.11 * The patient's weight is less than 1000 gm, the initial dose was 15 mg/kg body weight, and the suspense doses are 7.5 mg/kg body weight every 8 hours for 3 days (10 doses in total).11 * Intravenous dose * Intravenous paracetamol dose 15 mg/kg body weight every 6 hours for 3 days (12 doses in total).12 * After the 3-day follow up echocardiogram will be done.12 This will be the end of randomization for the purpose of the study.

Sponsors & Collaborators

  • Assiut University

    collaborator OTHER

  • Soha mahmoud Hussien mahdy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-11-01
Completion
2024-12-30

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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 NCT06256211 on ClinicalTrials.gov