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

• Conditions: Prematurity

• Registration Number: NCT03532633
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 23+0-42+6 SSW

Exclusion Criteria

• congenital malformation, genetic disorders
• metabolic disease of the infant
• missing agreement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of purine and pyrimidine in cord plasma	at birth

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Children's Hospital Tuebingen; 🇩🇪 Tuebingen, Germany