Amino Acid Profile in the Fetus and the Neonate

June 8, 2010 updated by: Sheba Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Leah Leibovitch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Term and preterm newborn infants

Description

Inclusion Criteria:

  • All new-born infants 5 of each gestational age

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2010

Last Update Submitted That Met QC Criteria

June 8, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • SHEBA-10-7895-LL-SMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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