Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study

Study Overview
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Brief Summary
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Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied

Detailed Description
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Collection of: cord plasma in preterm and term infants. remnants of clinically indicated blood samples of mothers 24 hours before or after birth. remnants of clinically indicated blood samples of preterm and term infants during neonatal care. 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.

Official Title
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Beobachtungsstudie Zur Versorgung Reif- Und Frühgeborener Mit ausgewählten Mikronährstoffen Wissenschaftliche Untersuchung Bei Minderjährigen

Conditions
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Prematurity

Intervention / Treatment
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* Procedure: cord blood
* Procedure: blood sample infant
* Procedure: blood sample mother
* Procedure: breast milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 23+0-42+6 SSW Exclusion Criteria: congenital malformation, genetic disorders metabolic disease of the infant missing agreement

Ages Eligible for Study
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Minimum Age: 0 Minutes
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 23-27w<br>preterm infants 23+0-27+6SSW | Procedure: cord blood<br>* collection of cord blood<br>Procedure: blood sample infant<br>* collection of remnant of clinically indicated blood sample<br>Procedure: blood sample mother<br>* collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed<br>Procedure: breast milk<br>* collection of breast milk 1/week during neonatal care (maximum 8 weaks)<br>|
| 28-31w<br>preterm infants 28+0-31+6SSW | Procedure: cord blood<br>* collection of cord blood<br>Procedure: blood sample infant<br>* collection of remnant of clinically indicated blood sample<br>Procedure: blood sample mother<br>* collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed<br>Procedure: breast milk<br>* collection of breast milk 1/week during neonatal care (maximum 8 weaks)<br>|
| 32-34w<br>preterm infants 32+0 - 34+6SSW | Procedure: cord blood<br>* collection of cord blood<br>Procedure: blood sample infant<br>* collection of remnant of clinically indicated blood sample<br>Procedure: blood sample mother<br>* collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed<br>Procedure: breast milk<br>* collection of breast milk 1/week during neonatal care (maximum 8 weaks)<br>|
| 35-36w<br>preterm infants 35+0-36+6 SSW | Procedure: cord blood<br>* collection of cord blood<br>Procedure: blood sample infant<br>* collection of remnant of clinically indicated blood sample<br>Procedure: blood sample mother<br>* collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed<br>Procedure: breast milk<br>* collection of breast milk 1/week during neonatal care (maximum 8 weaks)<br>|
| 37-42w<br>term infants 37+0-42+6 | Procedure: cord blood<br>* collection of cord blood<br>Procedure: blood sample infant<br>* collection of remnant of clinically indicated blood sample<br>Procedure: blood sample mother<br>* collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed<br>Procedure: breast milk<br>* collection of breast milk 1/week during neonatal care (maximum 8 weaks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of purine and pyrimidine in cord plasma |  | at birth | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, cord, micronutrients, purine, pyrimidine