- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03765684
Faktorer som påvirker nyfødte kroppssammensetning og senere helse i Helsingfors fødselskohort 2018-2022 (HeBiCo)
Effekter av ulike foreldre- og svangerskapsfaktorer på avkoms kroppssammensetning og helse i senere liv i Helsingfors fødselskohort 2018-2022
In Helsinki Birth Cohort 2018-2022 a large, longitudinal and well-phenotyped birth cohort of infants and their parents will be established. Mothers, fathers/spouses and their children in Helsinki and Uusimaa Hospital District are recruited in the study and newborn composition of the children born in Helsinki Women's Hospital will be measured. Data on maternal and paternal diet quality, physical activity and depression during and after pregnancy will be collected and data from the hospital and national registers will be collected. Health of offspring and parents will be followed during their later life.
Studieoversikt
Status
Detaljert beskrivelse
Helsinki Birth Cohort 2018-2022 (HeBiCo) study is designed to find evidence between various intrauterine exposures and offspring adiposity and later health. It will be examined how different maternal (e.g. chronic diseases, ethnicity, BMI), and obstetric factors (e.g. gestational weight gain, diagnoses during pregnancy) as well as parental lifestyle and psychological aspects (e.g. diet quality, physical activity, depression and anxiety) are associated with newborn body composition and later health (e.g. obesity and neurocognitive health).
In the first phase of the study the participants are recruited on postnatal ward after delivery. The umbilical cord blood sample will be collected of all the neonates. After a consent the participants fill in the digital background, food frequency, depression and physical activity questionnaires. If the parents do not give their consent, the umbilical cord blood sample will be destroyed. Body composition of offspring will be assessed within 72 hours after birth. Registry data will be collected.
The second phase of the HeBiCo study is based on the HUS WomensHub treatment path and/or Apotti platform. The second phase of the HeBiCo constitutes of the mother-child pairs (and fathers/spouses) whose pregnancy can be followed from the early pregnancy to the end of the pregnancy through treatment path. Body composition of offspring born in Helsinki Women's Hospital will be assessed within 72 hours after birth.
The future studies will include 1) the intervention studies with digital service concept through WomensHub platform, and 2) the follow-up studies of offspring and parents in later life (to establish e.g. growth trajectories and later metabolic health of offspring).
The first phase of the HeBiCo study was registered 3/2018.
The second phase will be registered now.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Helsinki, Finland, 00029
- HUS Women's hospital, Helsinki Unversity Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
The first phase of the Helsinki Birth Cohort (HeBiCo) will be constituted of all the neonates whose body composition at birth can be obtained at Helsinki Women's Hospital, and whose mothers and fathers/spouses fill out the questionnaires after delivery (background, food frequency (FFQ), and depression questionnaires (EPDS, CES-D)).
In the second phase of HeBiCo, participants will be recruited any time during pregnancy and also at postnatal ward after delivery.
Beskrivelse
Inclusion Criteria:
Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District.
Exclusion Criteria:
Inability to communicate in Finnish language
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neonatal body fat %
Tidsramme: Within 72 hours of birth
|
Measured with PEA POD Cosmed® Infant Body Composition Assessment system |
Within 72 hours of birth
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Newborn weight
Tidsramme: Within 2 hours of birth
|
Birth weight in kilograms |
Within 2 hours of birth
|
|
Newborn height
Tidsramme: Within 2 hours of birth
|
Birth height in meters |
Within 2 hours of birth
|
|
ASQ-3
Tidsramme: 3 months, 1 year and 2 years of age
|
Ages and Stages Questionnaire-3 |
3 months, 1 year and 2 years of age
|
|
ITSEA
Tidsramme: 3 months, 1 year and 2 years of age
|
Infant Toddler Social Emotional Assessment |
3 months, 1 year and 2 years of age
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Saila SB Koivusalo, Helsinki University Hospital, Women's Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HUS/180/2018, HUS/512/2019
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .