Prematurity
Conditions
Keywords
infant, cord, micronutrients, purine, pyrimidine
Brief summary
Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied
Detailed description
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.
Interventions
PROCEDUREcord blood
collection of cord blood
PROCEDUREblood sample infant
collection of remnant of clinically indicated blood sample
PROCEDUREblood sample mother
collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
PROCEDUREbreast milk
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
Sponsors
University Hospital Tuebingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Minutes to 6 Months
Healthy volunteers
No
Inclusion criteria
* 23+0-42+6 SSW
Exclusion criteria
* congenital malformation, genetic disorders * metabolic disease of the infant * missing agreement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of purine and pyrimidine in cord plasma | at birth |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of purine and pyrimidine in neonatal plasma | at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants) |
| Concentration of purine and pyrimidine in breast milk | once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks |
| Concentration of purine and pyrimidine in plasma of mothers | 24 hours before and after birth |
Countries
Germany
Contacts
Primary ContactKatrin Böckmann
Backup ContactAxel Franz
Outcome results
None listed