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- Registre américain des essais cliniques
- Essai clinique NCT03765684
Facteurs affectant la composition corporelle du nouveau-né et sa santé ultérieure dans la cohorte de naissance d'Helsinki 2018-2022 (HeBiCo)
Effets de divers facteurs parentaux et gestationnels sur la composition corporelle et la santé de la progéniture plus tard dans la vie dans la cohorte de naissance d'Helsinki 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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Helsinki, Finlande, 00029
- HUS Women's hospital, Helsinki Unversity Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
Inclusion Criteria:
Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District.
Exclusion Criteria:
Inability to communicate in Finnish language
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Neonatal body fat %
Délai: Within 72 hours of birth
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Measured with PEA POD Cosmed® Infant Body Composition Assessment system |
Within 72 hours of birth
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Newborn weight
Délai: Within 2 hours of birth
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Birth weight in kilograms |
Within 2 hours of birth
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Newborn height
Délai: Within 2 hours of birth
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Birth height in meters |
Within 2 hours of birth
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ASQ-3
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Saila SB Koivusalo, Helsinki University Hospital, Women's Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HUS/180/2018, HUS/512/2019
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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