Insulin Food Supplement for Preterm Infants

This study is currently recruiting participants.
Verified April 2012 by Laniado Hospital
Sponsor:
Collaborator:
Nutrinia
Information provided by (Responsible Party):
Laniado Hospital
ClinicalTrials.gov Identifier:
NCT01093638
First received: March 24, 2010
Last updated: April 17, 2013
Last verified: April 2012
  Purpose

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.

OBJECTIVES:

  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


Condition Intervention Phase
Premature Birth of Newborn
Very Low Birth Weight Baby
Intestinal Maturation
Abnormal Intestinal Absorption
Dietary Supplement: Insulin supplement
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.

Resource links provided by NLM:


Further study details as provided by Laniado Hospital:

Primary Outcome Measures:
  • Number of days to achieve complete enteral feeding [ Time Frame: Up to 28 days or discharge and at 3 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of gastric residual > 2 ml/kg [ Time Frame: Up to 28 days or discharge, at 3 months of age ] [ Designated as safety issue: No ]
  • Number of gastric residual > 50% of previous feeding [ Time Frame: Up to 28 days or discharge and at 3 months of age ] [ Designated as safety issue: No ]
  • Number of days to discharge [ Time Frame: Up to 28 days or discharge and at 3 months of age ] [ Designated as safety issue: No ]
  • Weight gain [ Time Frame: Up to 28 days or discharge and at 3 months of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin, food additive
Premature infant formula supplemented with insulin
Dietary Supplement: Insulin supplement
Premature infants will be fed with a formula supplemented with Insulin (400μU Insulin/ml formula)every 3 hours.
Other Name: Insumeal
Placebo Comparator: Control group
Premature infant formula supplemented with placebo
Dietary Supplement: Placebo
Premature infants will receive a placebo supplemented infant formula every 3 hours
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   26 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pre-term infants 26-33 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and early antenatal ultrasound.
  2. Birth weight ≥ 750 gr.
  3. Postnatal age ≤ 7 days.
  4. Fraction of inspired oxygen < 0.60 at enrollment.
  5. The infant is in a cardiovascular stable condition.
  6. No breast feeding after study day 1.
  7. No heart and chest compression or any resuscitation drugs given to the infant during delivery
  8. Informed consent form signed by parents or legal guardian.

Exclusion Criteria:

  1. Pre-term infants age <26 or >33 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and early antenatal ultrasound.
  2. Birth weight ≤750 grams.
  3. Postnatal age ≥ 7 days.
  4. Fraction of inspired oxygen > 0.60 at enrollment.
  5. The infant is in cardiovascular instability
  6. Breast feeding after study day 1.
  7. Major congenital malformation - Infants with genetic metabolic or endocrine disorder diagnosed before enrollment (including disorders diagnosed after enrollment but are known to be congenital).
  8. High index of suspicion of infection before enrollment.
  9. Complete oral feeding.
  10. Infant developing necrotizing enterocolitis or is suspected of having necrotizing enterocolitis.
  11. Maternal diabetes.
  12. The infant is treated with Insulin
  13. NPO, nothing per os for any reason at the study entry.
  14. Heart and chest compression or any resuscitation drugs given to the infant during delivery
  15. Participation in another clinical study

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093638

Contacts
Contact: Yoram A Bental, MD 972-9-8609579 yabental@laniado.org.il

Locations
Israel
NICU, Laniado Hospital Recruiting
Natanya, Israel, 42150
Contact: Yoram A Bental, MD    972-9-8609579    yabental@laniado.org.il   
Principal Investigator: Yoram A Bental, MD         
Sponsors and Collaborators
Laniado Hospital
Nutrinia
Investigators
Study Director: Naim Shehadeh, Prof. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Laniado Hospital
ClinicalTrials.gov Identifier: NCT01093638     History of Changes
Other Study ID Numbers: CTILYAB004409LND10LaniadoH
Study First Received: March 24, 2010
Last Updated: April 17, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Birth Weight
Premature Birth
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014