- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03765684
Faktorer, der påvirker nyfødts kropssammensætning og senere helbred i Helsinki fødselskohorte 2018-2022 (HeBiCo)
Effekter af forskellige forældre- og svangerskabsfaktorer på afkoms kropssammensætning og sundhed i senere liv i Helsinki fødselskohorte 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.
Studieoversigt
Status
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Helsinki, Finland, 00029
- HUS Women's hospital, Helsinki Unversity Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
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ASQ-3
Tidsramme: 3 months, 1 year and 2 years of age
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Ages and Stages Questionnaire-3 |
3 months, 1 year and 2 years of age
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ITSEA
Tidsramme: 3 months, 1 year and 2 years of age
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Infant Toddler Social Emotional Assessment |
3 months, 1 year and 2 years of age
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Saila SB Koivusalo, Helsinki University Hospital, Women's Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HUS/180/2018, HUS/512/2019
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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