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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03532633
• Other study ID #: NEO-MICRO
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2020
• Source: University Hospital Tuebingen
• Contact: Katrin Böckmann
• Phone: +49707129
• Email: katrin.a.boeckmann[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• 23+0-42+6 SSW

Exclusion Criteria:

• congenital malformation, genetic disorders

• metabolic disease of the infant

• missing agreement

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Germany	University Children's Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of purine and pyrimidine in cord plasma		at birth
Secondary	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)
Secondary	Concentration of purine and pyrimidine in breast milk		once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks
Secondary	Concentration of purine and pyrimidine in plasma of mothers		24 hours before and after birth