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

16. september 2020 opdateret af: University Hospital Tuebingen

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

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Tuebingen, Tyskland, 72076
        • Rekruttering
        • University Children's Hospital Tuebingen
        • Kontakt:
        • Ledende efterforsker:
          • Axel Franz, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 sekund til 6 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

infants and preterm infants

Beskrivelse

Inclusion Criteria:

  • 23+0-42+6 SSW

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Concentration of purine and pyrimidine in cord plasma
Tidsramme: at birth
at birth

Sekundære resultatmål

Resultatmål
Tidsramme
Concentration of purine and pyrimidine in neonatal plasma
Tidsramme: 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)
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
Tidsramme: once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks
once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks
Concentration of purine and pyrimidine in plasma of mothers
Tidsramme: 24 hours before and after birth
24 hours before and after birth

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Tuebingen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2017

Primær færdiggørelse (Forventet)

1. oktober 2021

Studieafslutning (Forventet)

1. oktober 2021

Datoer for studieregistrering

Først indsendt

9. maj 2018

Først indsendt, der opfyldte QC-kriterier

9. maj 2018

Først opslået (Faktiske)

22. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NEO-MICRO

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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