Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study
NCT ID: NCT03532633
Last Updated: 2020-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2017-03-01
2021-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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23-27w
preterm infants 23+0-27+6SSW
cord blood
collection of cord blood
blood sample infant
collection of remnant of clinically indicated blood sample
blood sample mother
collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
breast milk
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
28-31w
preterm infants 28+0-31+6SSW
cord blood
collection of cord blood
blood sample infant
collection of remnant of clinically indicated blood sample
blood sample mother
collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
breast milk
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
32-34w
preterm infants 32+0 - 34+6SSW
cord blood
collection of cord blood
blood sample infant
collection of remnant of clinically indicated blood sample
blood sample mother
collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
breast milk
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
35-36w
preterm infants 35+0-36+6 SSW
cord blood
collection of cord blood
blood sample infant
collection of remnant of clinically indicated blood sample
blood sample mother
collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
breast milk
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
37-42w
term infants 37+0-42+6
cord blood
collection of cord blood
blood sample infant
collection of remnant of clinically indicated blood sample
blood sample mother
collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
breast milk
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
Interventions
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cord blood
collection of cord blood
blood sample infant
collection of remnant of clinically indicated blood sample
blood sample mother
collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
breast milk
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* metabolic disease of the infant
* missing agreement
0 Minutes
6 Months
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Axel Franz
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tuebingen
Locations
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University Children's Hospital Tuebingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NEO-MICRO
Identifier Type: -
Identifier Source: org_study_id
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