Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-26 @ 5:20 PM
Study NCT ID:
NCT03532633
Status:
UNKNOWN
Last Update Posted:
2020-09-18
First Post:
2018-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study
Sponsor:
University Hospital Tuebingen
Organization:
Study Overview
Official Title:
Beobachtungsstudie Zur Versorgung Reif- Und Frühgeborener Mit ausgewählten Mikronährstoffen Wissenschaftliche Untersuchung Bei Minderjährigen
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: