Synthesis of Glutathione From Low Birth Weight Newborn Babies

NCT00607061 | Terminated

• 1 other identifier: 06/12-O
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Birth Weight

Keywords

Glutathione; Cysteine; Synthesis rate; Newborns; Low birth weight newborn babies

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

1

OTHER

Full term newborn babies with gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile.

Procedure: Blood sample collection

2

OTHER

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

3

OTHER

Full term newborn babies (gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile).

Procedure: Blood sample collection

Interventions

Blood sample collection PROCEDURE

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.

1; 2; 3

Eligibility Criteria

• Age: Up to 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full term newborn babies
• Gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile
• Eutocic delivery
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, Nantes, 44000, France

Location

Related Publications (1)

• De Luca A, Kuster A, Tea I, Darmaun D, Roze JC, Robins R, Hankard R. Plasma amino acid pools in the umbilical cord artery show lower 15N natural isotope abundance relative to the maternal venous pools. Isotopes Environ Health Stud. 2021 Mar;57(1):3-10. doi: 10.1080/10256016.2020.1817914. Epub 2020 Sep 24.

  PMID: 32972258 DERIVED

Study Officials

• Alice KUSTER, Doctor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Norbert WINER, Doctor

  Nantes University Hospital

  STUDY CHAIR

• Jean-Christophe ROZE, Professor

  Nantes University Hospital

  STUDY CHAIR

• Dominique DARMAUN, Professor

  Nantes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 30, 2013

Record last verified: 2013-09

Locations

FR (1)