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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Montefiore Medical Center

Current Primary Outcome:

• Time to regain birthweight in infants who receive L-carnitine supplementation compared to controls [ Time Frame: 3 weeks of age ]
• Measure motor development indices in infants who receive L-carnitine supplementation compared to controls [ Time Frame: up to 60 months ]
  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 ]
  Assessments will be made at term equivalent age, 2 years and 5 years of age.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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 ]
  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 ]
• Measure rate of head growth in infants who receive L-carnitine supplementation compared to controls [ Time Frame: until term equivalent age ]
  Measurements will be made at birth and then twice weekly for 4 weeks, then once a week until discharge.

Original Secondary Outcome: Same as current

Information By: Montefiore Medical Center

Dates:
Date Received: January 25, 2013
Date Started: January 2013
Date Completion: August 2020
Last Updated: September 21, 2015
Last Verified: September 2015