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

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ClinicalTrials.gov Identifier: NCT03532633
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Prematurity 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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Beobachtungsstudie Zur Versorgung Reif- Und Frühgeborener Mit ausgewählten Mikronährstoffen Wissenschaftliche Untersuchung Bei Minderjährigen
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

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)




Primary Outcome Measures :
  1. Concentration of purine and pyrimidine in cord plasma [ Time Frame: at birth ]

Secondary Outcome Measures :
  1. Concentration of purine and pyrimidine in neonatal plasma [ Time Frame: 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) ]
  2. Concentration of purine and pyrimidine in breast milk [ Time Frame: once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks ]
  3. Concentration of purine and pyrimidine in plasma of mothers [ Time Frame: 24 hours before and after birth ]


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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
infants and preterm infants
Criteria

Inclusion Criteria:

  • 23+0-42+6 SSW

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532633


Contacts
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Contact: Katrin Böckmann +49707129 ext 82621 katrin.a.boeckmann@gmail.com
Contact: Axel Franz +49707129 ext 83791 axel.franz@med.uni-tuebingen.de

Locations
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Germany
University Children's Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Axel Franz, MD    +497071290    axel.franz@med.uni-tuebingen.de   
Principal Investigator: Axel Franz, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Axel Franz University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03532633     History of Changes
Other Study ID Numbers: NEO-MICRO
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Tuebingen:
infant
cord
micronutrients
purine
pyrimidine