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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00607061
Acronym
glutathione
Enrollment
35
Registered
2008-02-05
Start date
2007-10-31
Completion date
2010-07-31
Last updated
2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Birth Weight

Keywords

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

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.

Interventions

PROCEDUREBlood 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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 9 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026