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Synthesis of Glutathione From Low Birth Weight Newborn Babies

NCT ID: NCT00607061

Last Updated: 2013-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Birth Weight

Keywords

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Glutathione Cysteine Synthesis rate Newborns Low birth weight newborn babies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

Blood sample collection

Intervention Type 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.

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.

Group Type OTHER

Blood sample collection

Intervention Type 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.

3

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

Group Type OTHER

Blood sample collection

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Alice KUSTER, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Norbert WINER, Doctor

Role: STUDY_CHAIR

Nantes University Hospital

Jean-Christophe ROZE, Professor

Role: STUDY_CHAIR

Nantes University Hospital

Dominique DARMAUN, Professor

Role: STUDY_CHAIR

Nantes University Hospital

Locations

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CHU de Nantes

Nantes, Nantes, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32972258 (View on PubMed)

Other Identifiers

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06/12-O

Identifier Type: -

Identifier Source: org_study_id