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.

Neonatal Sepsis

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.

Montelukast Sodium

Mansoura University Childran Hospital

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

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.

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 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 (receiving mechanical ventilation or CPAP) and the duration

duration of inotropes (dopamine, epinephrine, norepinephrine)

Hanan El-Halaby

Principal investigator

Mansoura University Children Hospital

The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication, and will be dispensed once a day on Monday, Wednesday, and Friday.

Patients will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will be not be adjusted if a new weight is obtained during the trial period.

The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.

Placebo

The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.

Azithromycin

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Gestational Age

Number of Participants who Received Synagis Injection

Number of Patients with Tracheostomy

Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.

Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)

Number of Adverse Events

Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.

Healthcare Cost Associated With Respiratory Illness

To determine if prophylactic use of azithromycin will reduce the total number of unscheduled face-to-face physician visit for respiratory related illness in a clinic, urgent care, emergency room or hospital setting during the following 12 months after the intervention.

Long Term Reduction in Respiratory Symptoms

To determine if prophylactic use of azithromycin will reduce level of airway resistance as measured by an Airwave Oscillometry System in subjects above 2 years of age, at the time of respiratory illnesses, during the 3-6 months intervention.

Level of Airway Conductance

Using a standardize nasal wash procedure, respiratory samples will be collected at enrollment, at end of study, and during acute respiratory illness requiring face-to-face provider interaction. Children with a tracheostomy will have both a nasal wash sample and a tracheal aspirate sample collected. The respiratory samples will be stabilized with a universal transport media, processed and stored at -80 C for future testing. Testing will be performed for cytokines/chemokines; other biomarkers of disease such as LDH, MPO, and caspase; viral and bacterial respiratory pathogens; and microbiome.

Level of Cytokines

Overall Study

Ricardo A. Mosquera, MD

Chronic Lung Disease

Patients will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.

Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.

bronchopulmonary dysplasia/diarrea

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

The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease

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