Synthesis of Glutathione From Low Birth Weight Newborn Babies

Low Birth Weight Clinical Trial

— glutathione  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00607061
• Other study ID #: 06/12-O
• Status: Terminated
• Phase: N/A
• First received: January 22, 2008
• Last updated: September 27, 2013
• Start date: October 2007
• Est. completion date: July 2010

Study information

• Verified date: September 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 9 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Low Birth Weight

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			Yes