An interventional study of Blood sample collection in Low Birth Weight, sponsored by Nantes University Hospital. Terminated at 1 site in France. Open to participants aged Up to 9 Months. Per ClinicalTrials.gov, last updated 2013-09-30.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Health services research
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.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 35 is below the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Inclusion Criteria (first step):
Inclusion Criteria (second step):
Exclusion criteria (first and second step):
Full term newborn babies with gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile.
Procedure: Blood sample collection
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
Full term newborn babies (gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile).
Procedure: 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.
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.
This study is terminated, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital