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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro

Resource links provided by NLM:

Drug Information available for: Cysteine Glutathione Cysteine hydrochloride

U.S. FDA Resources

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. [ Designated as safety issue: Yes ]

Enrollment:	35
Study Start Date:	October 2007
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	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):

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

Contacts and Locations

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

Locations

France
CHU de Nantes
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

No publications provided

ClinicalTrials.gov Identifier:	NCT00607061 History of Changes
Other Study ID Numbers:	06/12-O
Study First Received:	January 22, 2008
Last Updated:	July 27, 2010
Health Authority:	France: Direction Générale de la Santé

Keywords provided by Nantes University Hospital:

Glutathione
Cysteine
Synthesis rate
Newborns
Low birth weight newborn babies

Additional relevant MeSH terms:

Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012