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

Primary Purpose

Low Birth Weight

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample collection
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Low Birth Weight focused on measuring Glutathione, Cysteine, Synthesis rate, Newborns, Low birth weight newborn babies

Eligibility Criteria

undefined - 9 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nantes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

1

2

3

Arm Description

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

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).

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2008
Last Updated
September 27, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00607061
Brief Title
Synthesis of Glutathione From Low Birth Weight Newborn Babies
Acronym
glutathione
Official Title
Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight
Keywords
Glutathione, Cysteine, Synthesis rate, Newborns, Low birth weight newborn babies

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Full term newborn babies with gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile.
Arm Title
2
Arm Type
Other
Arm Description
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.
Arm Title
3
Arm Type
Other
Arm Description
Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile).
Intervention Type
Procedure
Intervention Name(s)
Blood sample collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice KUSTER, Doctor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert WINER, Doctor
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean-Christophe ROZE, Professor
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dominique DARMAUN, Professor
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32972258
Citation
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.
Results Reference
derived

Learn more about this trial

Synthesis of Glutathione From Low Birth Weight Newborn Babies

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