Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Montefiore Medical Center
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Mamta Fuloria, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01783041
First received: January 25, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life. The micronutrient carnitine, which is present in breast milk and stored in the fetus late in pregnancy, has been shown to protect against brain injury in animal studies. Without supplementation, almost all preterm infants develop carnitine deficiency soon after birth. Thus it is important to determine if carnitine supplementation protects against brain injury and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will not develop carnitine deficiency and will have improved growth in the first two weeks of life and higher scores on developmental tests when compared to control infants who did not receive carnitine.


Condition Intervention Phase
Prematurity
Neurodevelopmental Disorder
Carnitine Deficiency
Drug: L-carnitine
Drug: 5% Dextrose
Phase 2
Phase 3

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: Prevention
Official Title: A Double-Blind, Controlled, Randomized Clinical Trial of the Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Time to regain birthweight in infants who receive L-carnitine supplementation compared to controls [ Time Frame: 3 weeks of age ] [ Designated as safety issue: No ]
  • Measure motor development indices in infants who receive L-carnitine supplementation compared to controls [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]
    Assessments will be performed at term equivalent age, 2 years and 5 years.

  • Measure mental development indices in infants who receive L-carnitine supplementation compared to controls [ Time Frame: up to 60 months of age ] [ Designated as safety issue: No ]
    Assessments will be made at term equivalent age, 2 years and 5 years of age.


Secondary Outcome Measures:
  • Measure brain maturation as measured by amplitude-integrated EEG measurement in infants who received L-carnitine supplementation compared to controls [ Time Frame: until term equivalent age ] [ Designated as safety issue: No ]
    Measurement will be made at study initiation, and then every 2 weeks until term equivalent age

  • Measure white matter development, brain volumes and brain metabolism in infants who received L-carnitine supplementation compared to controls [ Time Frame: At 36 weeks' corrected age ] [ Designated as safety issue: No ]
  • Measure rate of head growth in infants who receive L-carnitine supplementation compared to controls [ Time Frame: until term equivalent age ] [ Designated as safety issue: No ]
    Measurements will be made at birth and then twice weekly for 4 weeks, then once a week until discharge.


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 5% dextrose
Infants randomized to the placebo group will receive 5% dextrose intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of placebo (5% Dextrose) will be given to the study patients.
Drug: 5% Dextrose
Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients.
Other Name: 5% Dextrose
Experimental: L-carnitine
Infants randomized to the study group will receive L-carnitine intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.
Drug: L-carnitine
Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.
Other Names:
  • Levocarnitine
  • L-carnitine
  • Carnitor

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants born at equal to or less than 30 weeks gestation and with birth weight < 1250 grams
  • Less than 72 hours of age
  • Signed parental consent

Exclusion Criteria:

  • Critically ill infants with life expectancy less than 72 hours
  • Inability to obtain consent within 72 hours of birth
  • Potentially life-threatening congenital anomalies
  • Known hereditary metabolic disorders
  • Known chromosomal abnormalities
  • Terratogen exposure with symptomatic substance withdrawal
  • Congenital viral infections
  • Microcephaly
  • Grade IV intraventricular hemorrhage or seizures documented within the first 72 hours of life
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783041

Contacts
Contact: Mamta Fuloria, MD 718-904-4105 ext 2821 mfuloria@montefiore.org
Contact: Deborah Campbell, MD 719-904-4105 ext 4119 dcampbel@montefiore.org

Locations
United States, New York
Montefiore Medical Center - Jack D. Weiler Division Recruiting
Bronx, New York, United States, 10461
Contact: Mamta Fuloria, MD    718-904-4105 ext 2821    mfuloria@montefiore.org   
Contact: Deborah Campbell, MD    718-904-4105 ext 4119    dcampbel@montefiore.org   
Sub-Investigator: Deborah Campbell, MD         
Sub-Investigator: Marie A Clark, MD, MPH         
Sub-Investigator: Nora Esteban-Cruciani, MD, MS         
Sub-Investigator: Ruth EK Stein, MD         
Sub-Investigator: William Gomes, MD         
Montefiore Medical Center - Wakefield Division Recruiting
Bronx, New York, United States, 10466
Contact: Mamta Fuloria, MD    718-904-4105 ext 2821    mfuloria@montefiore.org   
Contact: Deborah Campbell, MD    718-904-4105 ext 4119    dcampbel@montefiore.org   
Principal Investigator: Mamta Fuloria, MD         
Sub-Investigator: Elizabeth Hailu, MD         
Sub-Investigator: Deborah Campbell, MD         
Sub-Investigator: Marie A Clark, MD, MPH         
Sub-Investigator: Nora Esteban-Cruciani, MD         
Sub-Investigator: Ruth EK Stein, MD         
Sub-Investigator: William Gomes, MD         
Sponsors and Collaborators
Montefiore Medical Center
The Gerber Foundation
Investigators
Principal Investigator: Mamta Fuloria, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Mamta Fuloria, Assistant Professor, Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01783041     History of Changes
Other Study ID Numbers: 12-07-234
Study First Received: January 25, 2013
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
Prematurity
Carnitine supplementation
Neonatal Intensive Care
MRI
Amplitude-integrated EEG
NICU Network Neurobehavioral Scale
Bayley Scale of Infant Development III

Additional relevant MeSH terms:
Muscular Diseases
Cardiomyopathies
Hyperammonemia
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014