Prematurity Clinical Trial
Official title:
Beobachtungsstudie Zur Versorgung Reif- Und Frühgeborener Mit ausgewählten Mikronährstoffen Wissenschaftliche Untersuchung Bei Minderjährigen
Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied
Collection of:
1. cord plasma in preterm and term infants.
2. remnants of clinically indicated blood samples of mothers 24 hours before or after
birth.
3. remnants of clinically indicated blood samples of preterm and term infants during
neonatal care.
4. breast milk once a weak during neonatal care of the infant.
Determination concentrations of micronutrients by mass spectrometry.
Aim is to compare cord plasma concentrations with postnatal plasma concentrations and to
measure concentrations in breast milk to determine the actual supply.
Update September 2020:
The results obtained according to the original protocol revealed a serious sample instability
when using remnants of clinical blood samples. Remnants can not be used and therefore the
protocol had to be changed. A new approval of the Ethics Committee was obtained and is
available to the study team. The following changes for sample collection were implemented: an
additional blood sample (2.7ml EDTA blood) is taken from the mothers after approval.The blood
samples of premature and newborns (max. 3x 0.2 ml) are obtained when a clinically indicated
blood sample is taken. In both cases the serum is frozen immediately within one hour after
collection.
Due to these changes, the expected end of the study is postponed to 2021.
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