Status:
TERMINATED
Synthesis of Glutathione From Low Birth Weight Newborn Babies
Lead Sponsor:
Nantes University Hospital
Conditions:
Low Birth Weight
Eligibility:
All Genders
Up to 9 years
Phase:
NA
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 decre...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00607061
Start Date
October 1 2007
End Date
July 1 2010
Last Update
September 30 2013
Active Locations (1)
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1
CHU de Nantes
Nantes, Nantes, France, 44000