Clinical trial NCT03532633: Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study
Official title: Beobachtungsstudie Zur Versorgung Reif- Und Frühgeborener Mit ausgewählten Mikronährstoffen Wissenschaftliche Untersuchung Bei Minderjährigen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prematurity
Keywords: infant
cord
micronutrients
purine
pyrimidine
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants and preterm infants

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.

Eligibility criteria: Inclusion Criteria:

* 23+0-42+6 SSW

Exclusion Criteria:

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

Primary outcomes:
measure: Concentration of purine and pyrimidine in cord plasma
timeFrame: at birth
Secondary outcomes:
measure: Concentration of purine and pyrimidine in neonatal plasma
timeFrame: 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)
measure: Concentration of purine and pyrimidine in breast milk
timeFrame: once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks
measure: Concentration of purine and pyrimidine in plasma of mothers
timeFrame: 24 hours before and after birth
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Children's Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Axel Franz
role: PRINCIPAL_INVESTIGATOR
References: