Synthesis of Glutathione From Low Birth Weight Newborn Babies (glutathione)

This study has been terminated.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00607061
First received: January 22, 2008
Last updated: September 27, 2013
Last verified: September 2013

January 22, 2008
September 27, 2013
October 2007
July 2010   (final data collection date for primary outcome measure)
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 ]
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: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00607061 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Synthesis of Glutathione From Low Birth Weight Newborn Babies
Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Low Birth Weight
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.
  • 1
    Full term newborn babies with gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile.
    Intervention: Procedure: Blood sample collection
  • 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.
    Intervention: Procedure: Blood sample collection
  • 3
    Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile).
    Intervention: Procedure: Blood sample collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
up to 9 Months
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00607061
06/12-O
No
Not Provided
Nantes University Hospital
Not Provided
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
Nantes University Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP