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Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants

NCT04474327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-02-11

No results posted yet for this study

Summary

The investigators will conduct this study to explore the role of Montelukast in treatment of neonatal sepsis and whether it has an effect on inflammatory markers, the duration of antibiotic use, or on the patients´ outcome.

Conditions

  • Neonatal Sepsis

Interventions

DRUG

Montelukast Sodium

Montelukast sodium (Singulair) will be given at a dose according to body weight. Four mg of the drug will be dissolved in four ml milk and the dose will be given once daily at 9 pm for 10 days.

Sponsors & Collaborators

  • Mansoura University Children Hospital

    lead OTHER

Principal Investigators

  • Hanan A El-Halaby · Mansoura University Children Hospital, Gomhuria street, 35116 Mansoura, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2021-02-10
Completion
2021-02-10

Countries

  • Egypt

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 NCT04474327 on ClinicalTrials.gov