Synthesis of Glutathione From Low Birth Weight Newborn Babies - Full Text View

Purpose

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.

Condition	Intervention
Low Birth Weight	Procedure: Blood sample collection

Drug Information available for:

Cysteine Cysteine hydrochloride Glutathione

U.S. FDA Resources

Study Type:	Observational

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

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

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. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	42
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Full term newborn babies with gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile.	Procedure: Blood sample collection Blood of the umbilical cord will be collected after delivery. A mother blood sample will be also collected in the few hours preceding delivery to determine glutathione and cysteine concentrations.
2 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.	Procedure: Blood sample collection Blood of the umbilical cord will be collected after delivery. A mother blood sample will be also collected in the few hours preceding delivery to determine glutathione and cysteine concentrations.
3 Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile).	Procedure: Blood sample collection Blood of the umbilical cord will be collected after delivery. A mother blood sample will be also collected in the few hours preceding delivery to determine glutathione and cysteine concentrations.

Eligibility

Ages Eligible for Study:	up to 9 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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):

Lowbirth 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 antioxydant minerals by the mother for the last 24 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607061

Contacts


Contact: Alice KUSTER, Doctor		alice.kuster@chu-nantes.fr

Locations


France
	CHU de Nantes	Recruiting
	Nantes, France, 44000

Sponsors and Collaborators

Nantes University Hospital

Investigators


Principal Investigator:	Alice KUSTER, Doctor	CHU Nantes

Study Chair:	Norbert WINER, Doctor	CHU Nantes

Study Chair:	Jean-Christophe ROZE, Professor	CHU Nantes

Study Chair:	Dominique DARMAUN, Professor	CHU Nantes

More Information

Study ID Numbers:	06/12-O
First Received:	January 22, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00607061
Health Authority:	France: Direction Générale de la Santé

Keywords provided by Nantes University Hospital:

Glutathione

Cysteine

Synthesis rate

Newborns

Low birth weight newborn babies

Study placed in the following topic categories:

Body Weight

Birth Weight

Signs and Symptoms

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00607061