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

Primary Purpose

Neonatal Sepsis

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Montelukast Sodium
Sponsored by
Mansoura University Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Sepsis focused on measuring Sepsis, Montelukast, TNF alpha, premature infant

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. 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).

Exclusion Criteria:

- 1. Infants presented initially with septic shock, multi-organ dysfunction syndrome (MODS), disseminated intravascular coagulopathy.

2. Infants with major congenital malformations 3. Infants with chromosomal aberrations 4. Postoperative patients.

Sites / Locations

  • Mansoura University Childran Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The duration of NICU admission
the total duration of NICU admission
Change in serum C-reactive protein (CRP) level
Serum C-reactive protein (CRP) level will be measured on admission and compare its level with the level at 10 days after receiving therapy. It will be measured in both groups
Patients improvement, deterioration (Clinically and laboratory) or death
Patients are considered 1.improved when manifested clinically by no respiratory distress, normal temperature, no oxygen support, no inotropes, alert, not lethargic, tolerate feeding, increasing in body weight and laboratory by normal CBC , normal CRP, Culture negative. 2. Partially improved if patient still on intravenous fluid therapy, still on oxygen support, still on inotropes, CRP decreasing but still positive, and CBC still abnormal. 3. Deteriorated if developed complication as coagulopathy, septic shock or MODS.
use of positive pressure ventilation and its duration
use of positive pressure ventilation (receiving mechanical ventilation or CPAP) and the duration
Duration of use of inotropes
duration of inotropes (dopamine, epinephrine, norepinephrine)

Full Information

First Posted
July 13, 2020
Last Updated
February 10, 2021
Sponsor
Mansoura University Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04474327
Brief Title
Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants
Official Title
Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Children Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
Detailed Description
Since inflammatory mediators play a crucial role in the pathophysiology of sepsis so anti-inflammatory treatment, Montelukast, could be a beneficial therapy. The investigators will conduct this pilot, open-labeled, randomized controlled intervention trial on 40 newborns admitted to NICU. The study will include late preterm infants with gestational age (34 weeks to less than 37 weeks) with clinical evidence of sepsis. The study included an intervention group (n=20) that will receive oral Montelukast for 10 days with antibiotics in addition to the conventional antibiotic therapy regimen according to NICU policy while the control group (n=20) will receive antibiotics in addition to the conventional antibiotic therapy regimen according to NICU policy. After obtaining a fully informed written consent from the neonate's parents or guardians, patients will be recruited and group allocated in the study by random pick up of closed opaque sealed envelopes. Patients will be observed clinically and by laboratory investigations along the duration of hospital admission through a structured collection sheet. Demographic data, cause of admission, clinical data (vital signs, activity, feeding intolerance, respiratory symptoms, duration of oxygen support, use of inotropes) will be recorded. Blood sampling will be performed twice in both groups, on admission, and 10 days after treatment. The following investigations will be carried out: complete blood picture, C-reactive protein (CRP), tumor necrosis factor-alpha (TNF alpha), blood culture, Serum creatinine, Liver enzymes, and INR. A lumbar puncture will be performed when the treating physicians suspect meningitis. Patients in both groups will be observed along the duration of hospital admission to detect the outcome. Patients in the intervention group, receiving Montelukast sodium (Singulair), 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, will be given 2 mg). This dose was previously prescribed and given to preterm neonates suffered from bronchopulmonary dysplasia by 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. Along the period of NICU admission, patients receiving Montelukast will be closely observed for the development of any of its side effects that including "diarrhea, colic, vomiting, fever or cough" (Adelsberg et al., 2005).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis
Keywords
Sepsis, Montelukast, TNF alpha, premature infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive antibiotics and other supportive measures according to the policy of neonatal units and patients' needs.
Intervention Type
Drug
Intervention Name(s)
Montelukast Sodium
Other Intervention Name(s)
Singulair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in serum tumor necrosis factor (TNF) Alpha level
Description
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.
Time Frame
Measured twice: on admission and 10 days after receiving therapy
Secondary Outcome Measure Information:
Title
The duration of NICU admission
Description
the total duration of NICU admission
Time Frame
Counting the total duration of NICU admission
Title
Change in serum C-reactive protein (CRP) level
Description
Serum C-reactive protein (CRP) level will be measured on admission and compare its level with the level at 10 days after receiving therapy. It will be measured in both groups
Time Frame
Measured twice: on admission and 10 days after receiving therapy
Title
Patients improvement, deterioration (Clinically and laboratory) or death
Description
Patients are considered 1.improved when manifested clinically by no respiratory distress, normal temperature, no oxygen support, no inotropes, alert, not lethargic, tolerate feeding, increasing in body weight and laboratory by normal CBC , normal CRP, Culture negative. 2. Partially improved if patient still on intravenous fluid therapy, still on oxygen support, still on inotropes, CRP decreasing but still positive, and CBC still abnormal. 3. Deteriorated if developed complication as coagulopathy, septic shock or MODS.
Time Frame
determined at 10 days after receiving therapy
Title
use of positive pressure ventilation and its duration
Description
use of positive pressure ventilation (receiving mechanical ventilation or CPAP) and the duration
Time Frame
determined at 10 days after receiving therapy
Title
Duration of use of inotropes
Description
duration of inotropes (dopamine, epinephrine, norepinephrine)
Time Frame
determined at 10 days after receiving therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. 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). Exclusion Criteria: - 1. Infants presented initially with septic shock, multi-organ dysfunction syndrome (MODS), disseminated intravascular coagulopathy. 2. Infants with major congenital malformations 3. Infants with chromosomal aberrations 4. Postoperative patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanan A El-Halaby
Organizational Affiliation
Mansoura University Children Hospital, Gomhuria street, 35116 Mansoura, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Childran Hospital
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35116
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
15969897
Citation
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.
Results Reference
background
PubMed Identifier
26512261
Citation
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.
Results Reference
result

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

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