Synthesis of Glutathione From Low Birth Weight Newborn Babies

Study Overview
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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.

Official Title
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Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro

Conditions
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Low Birth Weight

Intervention / Treatment
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* Procedure: Blood sample collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Full term newborn babies with gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile. | Procedure: Blood sample collection<br>* 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.<br>|
| Other: 2<br>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<br>* 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.<br>|
| Other: 3<br>Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile). | Procedure: Blood sample collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glutathione, Cysteine, Synthesis rate, Newborns, Low birth weight newborn babies