DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Synthesis of Glutathione From Low Birth Weight Newborn Babies

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Birth Weight

Intervention: Blood sample collection (Procedure)

Phase: N/A

Status: Terminated

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Alice KUSTER, Doctor, Principal Investigator, Affiliation: CHU Nantes
Norbert WINER, Doctor, Study Chair, Affiliation: CHU Nantes
Jean-Christophe ROZE, Professor, Study Chair, Affiliation: CHU Nantes
Dominique DARMAUN, Professor, Study Chair, Affiliation: CHU Nantes

Summary

The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms. The protocol is constituted of two steps. The objective of the first step is to quantify the blood concentration of glutathione in the artery and the vein of umbilical cord in full term newborn babies. Objectives of the second step are to determine if the glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from umbilical cord blood of low weight newborn babies compared to full term newborn babies. In this case, the next objective will be to determine if the adjunction of an excess of cysteine in vitro can restore the glutathione synthesis rate in these cells.

Clinical Details

Official title: Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: The glutathione concentration in umbilical cord in full term newborn babies, the glutathione concentration in umbilical cord of low birth weight newborn babies and the effect of the adjunction of an excess of cysteine on the glutathione synthesis rate.

Eligibility

Minimum age: N/A. Maximum age: 9 Months. Gender(s): Both.

Criteria:

Inclusion Criteria (first step):

- Full term newborn babies

- Gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile

- Eutocic delivery

Inclusion Criteria (second step):

- Low birth weight newborn babies (gestational age < 32 weeks of amenorrhea and/or

weight of birth < 1500 g and/or weight of birth < third percentile for their gestational age)

- Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of

birth > tenth percentile) Exclusion criteria (first and second step):

- Mother diastolic blood pressure > 90 mmHg during pregnancy,

- pH < 7. 2 at umbilical cord and/or difference in pH < 0,02 between arterial pH and

venous pH

- Dystocic delivery

- Bacterial or viral maternofoetal infection

- Foetal malformation

- Foetal disease

- Taking N-acetyl-cystein or vitamines and antioxidant minerals by the mother for the

last 24 hours

Locations and Contacts

CHU de Nantes, Nantes 44000, France
Additional Information

Starting date: October 2007
Last updated: September 27, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017