NCT03532633

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 0 Minutes – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity

Interventions

Type	Name	Description
PROCEDURE	cord blood	collection of cord blood
PROCEDURE	blood sample infant	collection of remnant of clinically indicated blood sample
PROCEDURE	blood sample mother	collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
PROCEDURE	breast milk	collection of breast milk 1/week during neonatal care (maximum 8 weaks)

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2018-05-22
• Last updated: 2020-09-18

Locations

1 site across 1 country: Germany