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

NCT04474327 | Completed Phase 1

• 1 other identifier: Montelukast in neonatal sepsis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sepsis; Montelukast; TNF alpha; premature infant

Outcome Measures

Primary Outcomes (1)

• Change in serum tumor necrosis factor (TNF) Alpha level

  Change in serum level of TNF alpha is assessed by the difference between the admission level and its level at 10 days after receiving the therapy.

  Measured twice: on admission and 10 days after receiving therapy

Secondary Outcomes (5)

• The duration of NICU admission

  Counting the total duration of NICU admission

• Change in serum C-reactive protein (CRP) level

  Measured twice: on admission and 10 days after receiving therapy

• Patients improvement, deterioration (Clinically and laboratory) or death

  determined at 10 days after receiving therapy

• use of positive pressure ventilation and its duration

  determined at 10 days after receiving therapy

• Duration of use of inotropes

  determined at 10 days after receiving therapy

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive Montelukast Sodium for 10 days in addition to the conventional antibiotic therapy regimen and other supportive measures according to the policy of neonatal units and patients' needs. Montelukast sodium will be given at a dose according to body weight (1.5 kg to 2 kg, will be given 1.5 mg; greater than 2 kg, 2 mg will be given) this dose was calculated according to ( Kim et al. (2015). Four mg of the drug will be dissolved in four ml milk and 1.5 - 2 ml milk only will be given once daily at 9 pm via an orogastric tube or by oral administration for 10 days and patients of this group will be closely observed for development of Montelukast side effects as "diarrhea, colic, vomiting, fever and cough" (Adelsberg et al. 2005).

Drug: Montelukast Sodium

Control group

NO INTERVENTION

The control group will receive antibiotics and other supportive measures according to the policy of neonatal units and patients' needs.

Interventions

Montelukast Sodium DRUG

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.

Also known as: Singulair

Intervention group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Infants with gestational age from 34 weeks to less than 37 weeks (late preterm) and weighted more than 1.5 Kg with clinical evidence of neonatal sepsis (Wynn 2016).

You may not qualify if:

• \- 1. Infants presented initially with septic shock, multi-organ dysfunction syndrome (MODS), disseminated intravascular coagulopathy.
• \. Infants with major congenital malformations 3. Infants with chromosomal aberrations 4. Postoperative patients.

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Childran Hospital

Al Mansurah, Dakahlia Governorate, 35116, Egypt

Location

Related Publications (2)

• van Adelsberg J, Moy J, Wei LX, Tozzi CA, Knorr B, Reiss TF. Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma. Curr Med Res Opin. 2005 Jun;21(6):971-9. doi: 10.1185/030079905X48456.

  PMID: 15969897 BACKGROUND

• Kim SB, Lee JH, Lee J, Shin SH, Eun HS, Lee SM, Sohn JA, Kim HS, Choi BM, Park MS, Park KI, Namgung R, Park MS. The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia. Korean J Pediatr. 2015 Sep;58(9):347-53. doi: 10.3345/kjp.2015.58.9.347. Epub 2015 Sep 21.

  PMID: 26512261 RESULT

MeSH Terms

Conditions

Neonatal Sepsis; Sepsis; Premature Birth

Interventions

montelukast

Condition Hierarchy (Ancestors)

Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hanan A El-Halaby

  Mansoura University Children Hospital, Gomhuria street, 35116 Mansoura, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: July 24, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

EG (1)