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

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

Study Overview

• Status: Unknown
• Conditions: Prematurity
• Intervention / Treatment: Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • Recruiting
    • University Children's Hospital Tuebingen
    • Contact: Axel Franz, MD; Phone Number: +497071290; Email: axel.franz@med.uni-tuebingen.de
    • Principal Investigator: Axel Franz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

infants and preterm infants

Description

Inclusion Criteria:

• 23+0-42+6 SSW

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
23-27w; preterm infants 23+0-27+6SSW	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)
28-31w; preterm infants 28+0-31+6SSW	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)
32-34w; preterm infants 32+0 - 34+6SSW	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)
35-36w; preterm infants 35+0-36+6 SSW	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)
37-42w; term infants 37+0-42+6	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of purine and pyrimidine in cord plasma	at birth

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: micronutrients; infant; cord; purine; pyrimidine
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NEO-MICRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No