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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01140698
Other study ID # SHEBA-10-7895-LL-SMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 8, 2010
Last updated June 8, 2010
Start date July 2010

Study information

Verified date June 2010
Source Sheba Medical Center
Contact Leah Leibovitch, MD
Phone 972-52-6667325
Email leah.leibovitch@gmail.com
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations. However, the growth rate is known to be reduced compared to the fetal growth rate. In order to attempt a better growth rate of the preterm newborn infants it is important to evaluate the metabolic components of the fetal blood and try to find components that might influence its growth.

Little is known of the metabolic components of the fetal blood, including amino acid profile. The aim of the study is to evaluate amino acid profile in the fetus blood in different gestational ages and compare it to post natal period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- All new-born infants 5 of each gestational age

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge
Mass spectroscopy on the blood sample that are taken as routine for the national inborn errors survey

Locations

Country Name City State
Israel Sheba medical center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel,