Clinical trial NCT00607061: Synthesis of Glutathione From Low Birth Weight Newborn Babies
Official title: Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Birth Weight
Keywords: Glutathione
Cysteine
Synthesis rate
Newborns
Low birth weight newborn babies
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 35
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: 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 outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Alice KUSTER, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Norbert WINER, Doctor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Jean-Christophe ROZE, Professor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Dominique DARMAUN, Professor
role: STUDY_CHAIR
References:
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.