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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 27, 2013
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:
Body Weight
Birth Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014