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

NCT ID: NCT04474327

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-24
• Study Completion Date: 2021-02-10

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).

Conditions

Neonatal Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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).

Group Type: EXPERIMENTAL

Montelukast Sodium

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Singulair

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Children Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hanan El-Halaby

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanan A El-Halaby

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Mansoura University Childran Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 15969897 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26512261 (View on PubMed)

Other Identifiers

Montelukast in neonatal sepsis

Identifier Type: -

Identifier Source: org_study_id