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GENERAL:The study will evaluate the effect of insulin food supplement on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol. The study will aim to determine whether an oral insulin supplement to the basic preterm formula enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds (150-160cc/kg/day). The insulin concentration supplemented in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.
1. To assess whether insulin enriched formula enhances gastrointestinal maturation by reducing the time required to reach full enteral feed in preterm infants.
2. To assess whether insulin enriched formula enhances gastrointestinal maturation by reducing the number of gastric residuals which are over 2 ml/kg and reducing the number of gastric residual which contain more then 50% of last feeding given content.
3. To assess whether insulin enriched formula reduces number of days to discharge from the neonatal ward.
4. To assess the safety of insulin enriched formula for premature infants by following all adverse events.
5. To assess the weight gain in the preterm infants.
STUDY DESIGN: A Multi-center,two arms, Randomized, Double-blinded placebo controlled
PRODUCT:InsuMeal™ - Insulin Food Supplement for Preterm Infants
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Insulin supplement, Placebo
Not yet recruiting
Published on BioPortfolio: 2014-07-24T14:06:45-0400
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Onset of OBSTETRIC LABOR before term (TERM BIRTH) but usually after the FETUS has become viable. In humans, it occurs sometime during the 29th through 38th week of PREGNANCY. TOCOLYSIS inhibits premature labor and can prevent the BIRTH of premature infants (INFANT, PREMATURE).
A chronic lung disease developed after OXYGEN INHALATION THERAPY or mechanical ventilation (VENTILATION, MECHANICAL) usually occurring in certain premature infants (INFANT, PREMATURE) or newborn infants with respiratory distress syndrome (RESPIRATORY DISTRESS SYNDROME, NEWBORN). Histologically, it is characterized by the unusual abnormalities of the bronchioles, such as METAPLASIA, decrease in alveolar number, and formation of CYSTS.
Diseases that occur in PREMATURE INFANTS.
A condition of the newborn marked by DYSPNEA with CYANOSIS, heralded by such prodromal signs as dilatation of the alae nasi, expiratory grunt, and retraction of the suprasternal notch or costal margins, mostly frequently occurring in premature infants, children of diabetic mothers, and infants delivered by cesarean section, and sometimes with no apparent predisposing cause.
A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...
Obstetrics and gynaecology
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