Insulin Food Supplement for Preterm Infants

2014-07-24 14:06:45 | BioPortfolio


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

Study Design

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


Premature Infants


Insulin supplement, Placebo


Not yet recruiting


Laniado Hospital

Results (where available)

View Results


Published on BioPortfolio: 2014-07-24T14:06:45-0400

Clinical Trials [3445 Associated Clinical Trials listed on BioPortfolio]

Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants

This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group...

The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants

SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have...

Prophylactic Probiotics in Premature Infants

This study tries to determine whether the oral administration of a specific probiotic (good bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent infect...

Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants

At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed t...

Introduction and Maintenance of Still Eating Protein Blends in Support of Infant Nutritional Goals

The purpose of the study is to test a food supplement to: - Show that the food supplement is well tolerated and safe to feed to infants; - Find out how often parents/caregivers fee...

PubMed Articles [4975 Associated PubMed Articles listed on BioPortfolio]

Nebulized salbutamol diminish the blood glucose fluctuation in the treatment of non-oliguric hyperkalemia of premature infants.

Hyperkalemia is a risky and potentially life-threatening condition in pre-term infants. Glucose-insulin infusion has been considered a major therapeutic way for non-oligouric hyperkalemia but affects ...

Nonnutritive Sucking at the Mother's Breast Facilitates Oral Feeding Skills in Premature Infants: A Pilot Study.

Premature infants have difficulties in transitioning from gavage to breastfeeding. Targeted interventions to support breastfeeding in premature infants in the neonatal intensive care unit are scarce.

Increasing effort without noticing: A randomized controlled pilot study about the ergogenic placebo effect in endurance athletes and the role of supplement salience.

Previous research shows that endurance performance can be enhanced by placebo ergogenic aids. This study investigates the ergogenic placebo response, which we define as an increase in objective and ph...

Factors in Premature Infants Associated With Low Risk of Developing Retinopathy of Prematurity.

Most premature infants will not develop retinopathy of prematurity (ROP) of clinical relevance, yet screening evaluations often continue beyond hospital discharge, even for those infants without ROP.

A Synergistic Formulation of Plant Extracts Decreases Postprandial Glucose and Insulin Peaks: Results from Two Randomized, Controlled, Cross-Over Studies Using Real-World Meals.

This study investigated the efficacy of a plant-derived dietary supplement with respect to decreasing postprandial glucose and insulin peaks after the intake of real-world meals. Two randomized, doubl...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "Insulin Food Supplement for Preterm Infants"

Quick Search


Relevant Topics

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
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Searches Linking to this Trial