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NCT04474327
Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants
Phase 1 trial testing Montelukast Sodium in Neonatal Sepsis in 40 participants. Completed in 10 February 2021.
10 February 2021
Quick facts
| Lead sponsor | Mansoura University Children Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 24 July 2020 |
| Primary completion | 10 February 2021 |
| Estimated completion | 10 February 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Montelukast Sodium — full drug profile →
Conditions studied
- Neonatal Sepsis — all drugs for Neonatal Sepsis →
Sponsor
Mansoura University Children Hospital
Who can join
Adults 1 Day to 30 Days, any sex, with Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04474327
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Montelukast Sodium
Trials testing the same drug.
- NCT04613180 — Evaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis · Phase 4 · unknown
Other recruiting trials for Neonatal Sepsis
Currently open trials in the same condition.
- NCT07421323 — Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection · NA · recruiting
- NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting
Other Mansoura University Children Hospital trials
Trials by the same sponsor.
- NCT05589909 — Performance of Interleukin-27 Cord Blood Level as A Biomarker Predicating Early Onset Neonatal Sepsis · unknown
- NCT03731611 — Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency · NA · completed
- NCT05091008 — Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children · Phase 2 · completed
- NCT05596656 — IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study · completed
- NCT04958616 — House Dust Mites Sensitization and Level of Asthma Control and Severity in Children · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04474327 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University Children Hospital
- Last refreshed: 11 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04474327.
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