Last Verified: | June/30/2020 |
First Submitted: | July/12/2020 |
Estimated Enrollment Submitted: | July/14/2020 |
First Posted: | July/15/2020 |
Last Update Submitted: | July/23/2020 |
Last Update Posted: | July/26/2020 |
Actual Study Start Date: | July/23/2020 |
Estimated Primary Completion Date: | December/31/2020 |
Estimated Study Completion Date: | January/31/2021 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: 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). | Drug: Intervention group 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. |
No Intervention: Control group The control group will receive antibiotics and other supportive measures according to the policy of neonatal units and patients' needs. |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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. |