Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study
16. september 2020 oppdatert av: 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
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
Collection of:
- cord plasma in preterm and term infants.
- remnants of clinically indicated blood samples of mothers 24 hours before or after birth.
- remnants of clinically indicated blood samples of preterm and term infants during neonatal care.
- 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.
Studietype
Observasjonsmessig
Registrering (Forventet)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Tuebingen, Tyskland, 72076
- Rekruttering
- University Children's Hospital Tuebingen
-
Ta kontakt med:
- Axel Franz, MD
- Telefonnummer: +497071290
- E-post: axel.franz@med.uni-tuebingen.de
-
Hovedetterforsker:
- Axel Franz, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 sekund til 6 måneder (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
23-27w
preterm infants 23+0-27+6SSW
|
collection of cord blood
collection of remnant of clinically indicated blood sample
collection of remnant of clinically indicated blood sample.
If not available blood sample is taken after mother agreed
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
|
|
28-31w
preterm infants 28+0-31+6SSW
|
collection of cord blood
collection of remnant of clinically indicated blood sample
collection of remnant of clinically indicated blood sample.
If not available blood sample is taken after mother agreed
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
|
|
32-34w
preterm infants 32+0 - 34+6SSW
|
collection of cord blood
collection of remnant of clinically indicated blood sample
collection of remnant of clinically indicated blood sample.
If not available blood sample is taken after mother agreed
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
|
|
35-36w
preterm infants 35+0-36+6 SSW
|
collection of cord blood
collection of remnant of clinically indicated blood sample
collection of remnant of clinically indicated blood sample.
If not available blood sample is taken after mother agreed
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
|
|
37-42w
term infants 37+0-42+6
|
collection of cord blood
collection of remnant of clinically indicated blood sample
collection of remnant of clinically indicated blood sample.
If not available blood sample is taken after mother agreed
collection of breast milk 1/week during neonatal care (maximum 8 weaks)
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2017
Primær fullføring (Forventet)
1. oktober 2021
Studiet fullført (Forventet)
1. oktober 2021
Datoer for studieregistrering
Først innsendt
9. mai 2018
Først innsendt som oppfylte QC-kriteriene
9. mai 2018
Først lagt ut (Faktiske)
22. mai 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. september 2020
Sist bekreftet
1. september 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NEO-MICRO
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .