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

NCT03532633 | Unknown

• 1 other identifier: NEO-MICRO
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prematurity

Keywords

infant; cord; micronutrients; purine; pyrimidine

Outcome Measures

Primary Outcomes (1)

• Concentration of purine and pyrimidine in cord plasma

  at birth

Secondary Outcomes (3)

• 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

Study Arms (5)

23-27w

preterm infants 23+0-27+6SSW

Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk

28-31w

preterm infants 28+0-31+6SSW

Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk

32-34w

preterm infants 32+0 - 34+6SSW

Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk

35-36w

preterm infants 35+0-36+6 SSW

Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk

37-42w

term infants 37+0-42+6

Procedure: cord blood; Procedure: blood sample infant; Procedure: blood sample mother; Procedure: breast milk

Interventions

cord blood PROCEDURE

collection of cord blood

23-27w; 28-31w; 32-34w; 35-36w; 37-42w

blood sample infant PROCEDURE

collection of remnant of clinically indicated blood sample

23-27w; 28-31w; 32-34w; 35-36w; 37-42w

blood sample mother PROCEDURE

collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed

23-27w; 28-31w; 32-34w; 35-36w; 37-42w

breast milk PROCEDURE

collection of breast milk 1/week during neonatal care (maximum 8 weaks)

23-27w; 28-31w; 32-34w; 35-36w; 37-42w

Eligibility Criteria

• Age: 0 Minutes - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

infants and preterm infants

You may qualify if:

• +0-42+6 SSW

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Children's Hospital Tuebingen

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Premature Birth; Cone-Rod Dystrophies

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Axel Franz

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Böckmann

CONTACT

+49707129; katrin.a.boeckmann@gmail.com

Axel Franz

CONTACT

+49707129; axel.franz@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: March 1, 2017
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)