Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Amino Acid Profile in the Fetus and the Neonate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01140698
First received: June 8, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Cord Blood Amino Acid Profile
Fetal Amino Acid Profile in Different Gestational Ages
Infant Amino Acid Profile at Day 3 and Discharge
Other: Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 180
Study Start Date: July 2010
Groups/Cohorts Assigned Interventions
Term and preterm newborn infants
5 infants of each gestational age of 24-42 weeks
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

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Term and preterm newborn infants

Criteria

Inclusion Criteria:

  • All new-born infants 5 of each gestational age

Exclusion Criteria:

  • none
  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: NCT01140698

Contacts
Contact: Leah Leibovitch, MD 972-52-6667325 leah.leibovitch@gmail.com

Locations
Israel
Sheba medical center Not yet recruiting
Ramat Gan, Israel, 52621
Contact: Leah Leibovitch, MD    972-52-6667325    leah.leibovitch@gmail.com   
Principal Investigator: Leah Leibovitch, MD         
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Leah Leibovitch, Shaba Medical Center
ClinicalTrials.gov Identifier: NCT01140698     History of Changes
Other Study ID Numbers: SHEBA-10-7895-LL-SMC
Study First Received: June 8, 2010
Last Updated: June 8, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on November 20, 2014