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Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied
Collection of:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 23-27w | preterm infants 23+0-27+6SSW |
| |
| 28-31w | preterm infants 28+0-31+6SSW |
| |
| 32-34w | preterm infants 32+0 - 34+6SSW |
| |
| 35-36w | preterm infants 35+0-36+6 SSW |
| |
| 37-42w | term infants 37+0-42+6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cord blood | Procedure | collection of cord blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of purine and pyrimidine in cord plasma | at birth |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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infants and preterm infants
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrin Böckmann | Contact | +49707129 | 82621 | katrin.a.boeckmann@gmail.com |
| Axel Franz | Contact | +49707129 | 83791 | axel.franz@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Axel Franz | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Tuebingen | Recruiting | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D000071700 | Cone-Rod Dystrophies |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| blood sample infant | Procedure | collection of remnant of clinically indicated blood sample |
|
| blood sample mother | Procedure | collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed |
|
| breast milk | Procedure | collection of breast milk 1/week during neonatal care (maximum 8 weaks) |
|
| 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 |
| D000091642 | Urogenital Diseases |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |