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

Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator

Standard bundling practices when removing the infant from the incubator. No plastic bag used.

Hypothermia

Upon removal from the incubator, infant will be placed into a plastic bag to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

Hypothermia prevention with plastic bag

Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

Hypothermia prevention without plastic bag

University Teaching Hospital

Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV

Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV

Temperature taken per axilla for one minute

Measure of extremity blood pressure per cuff taken during nursery stay

Measure of blood glucose per laboratory value taken per heel stick

Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.

Infant will be weighed daily and rates of weight gain will be calculated

Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant

Either chest radiograph documentation or clinical deterioration consistent with air leak

Culture proven or culture negative clinically treated course consistent with sepsis

Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound

Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1.

Blood seen in the endotracheal tube and treated by physician

Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute

Documentation of length of time spent in incubator and number of times placed in incubator

A recording of the room temperature and humidity will be obtained with each axillary temperature measurement

A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement

University of Alabama at Birmingham

Children's of Alabama

Placement into an incubator without a plastic bag

Placement into a plastic bag inside incubator

While being placed into an incubator, infant will be placed into a plastic bag to his/her axillae and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.

Incubator-torso bag

Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.

Incubator-no plastic bag

Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III

Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III

Temperature taken per axilla for 1 minute

Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.

Oxygen requirement at 28 days after birth

Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocoliities per Bell's Classification stage greater than 1.

Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute

A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement

Wally Carlo

Edwin M. Dixon Professor of Pediatrics

Children's Health System, Alabama

Plastic bag will be used during and after resuscitation to assist with temperature regulation.

Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.

Hypothermia, Newborn

Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

Resuscitation and post resuscitation care with plastic bag

Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

Resuscitation- no plastic bag for temperature regulation

Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries

Measure of extremity blood pressure per cuff taken during nursery stay.

Measure of blood glucose per laboratory value taken per heelstick

Infant will be weighed daily and rates of weight gain will be measured.

Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant.

Culture proven or culture negative clinically treated course consistent with sepsis.

Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound

Documentation of pneumatosis or intestinal perforation on x ray or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than one.

Blood seen in the endotracheal tube and treated by physician.

Alicia Leadford, MD

Fellow Instructor, Department of Pediatrics, Division of Neonatology

Respiratory Infection

Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.

Children's and Women's Health Centre of BC

Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics

Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics. A Randomized Controlled Trial of Decision Making Based Upon Early (at Triage) Rapid Diagnosis of Respiratory Viral Infections (VIRAP) in Children 3-36 Months of Age Presenting to the Emergency Department (ED) With a Flu-Like Illness.

bronchopulmonary dysplasia/fever

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

Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV

Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III

Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics

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