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

Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prematurity; Neurodevelopmental Disorder; Carnitine Deficiency

Intervention: L-carnitine (Drug); 5% Dextrose (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Montefiore Medical Center

Official(s) and/or principal investigator(s):
Mamta Fuloria, MD, Principal Investigator, Affiliation: Montefiore Medical Center

Overall contact:
Mamta Fuloria, MD, Phone: 718-904-4105, Ext: 2821, Email: mfuloria@montefiore.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Time to regain birthweight in infants who receive L-carnitine supplementation compared to controls

Measure motor development indices in infants who receive L-carnitine supplementation compared to controls

Measure mental development indices in infants who receive L-carnitine supplementation compared to controls

Secondary outcome:

Measure brain maturation as measured by amplitude-integrated EEG measurement in infants who received L-carnitine supplementation compared to controls

Measure white matter development, brain volumes and brain metabolism in infants who received L-carnitine supplementation compared to controls

Measure rate of head growth in infants who receive L-carnitine supplementation compared to controls

Eligibility

Minimum age: N/A. Maximum age: 3 Days. Gender(s): Both.

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

Locations and Contacts

Mamta Fuloria, MD, Phone: 718-904-4105, Ext: 2821, Email: mfuloria@montefiore.org

Montefiore Medical Center - Jack D. Weiler Division, Bronx, New York 10461, United States; Recruiting
Mamta Fuloria, MD, Phone: 718-904-4105, Ext: 2821, Email: mfuloria@montefiore.org
Deborah Campbell, MD, Phone: 718-904-4105, Ext: 4119, Email: dcampbel@montefiore.org
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, Sub-Investigator

Montefiore Medical Center - Wakefield Division, Bronx, New York 10466, United States; Recruiting
Mamta Fuloria, MD, Phone: 718-904-4105, Ext: 2821, Email: mfuloria@montefiore.org
Deborah Campbell, MD, Phone: 718-904-4105, Ext: 4119, Email: dcampbel@montefiore.org
Mamta Fuloria, MD, Principal 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, Sub-Investigator

Additional Information

Starting date: January 2013
Last updated: February 19, 2015

Page last updated: August 23, 2015

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