GenerationGemelli: Longitudinal Study for the Evaluation of the Maternal Exposome on the Health of the Newborn and Child

NCT06617650 | Recruiting

• 1 other identifier: 4975
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves the establishment of a case-control study within a birth cohort. With approximately 4,000 annual deliveries, the aim is to enroll 140 cases (newborns with intrauterine growth restriction \[IUGR\] and premature birth) and 280 controls each year, starting from September 2022. A comprehensive questionnaire will be utilized to gather information about various types of maternal environmental exposures before and during pregnancy. Biological samples will be collected from both mothers and newborns (including vaginal swab, placenta sample, blood, saliva, meconium, and bronchoalveolar lavage fluid) at birth and within the early hours of the newborn's life. Laboratory examinations will include the measurement of heavy metals and essential elements, investigation of placental distress and fetal brain damage biomarkers, analysis of microbiota, and assessment of DNA methylation profiles. Clinical follow-up assessments will be conducted in both cases and controls at 12 and 24 months, during which anthropometric data, types of feeding with particular reference to breastfeeding and its duration, pediatric emergency room visits, hospitalizations, medication usage, known allergies, and neuropsychological development will be collected.

Conditions

Maternal Exposure; Maternal Exposure During Pregnancy

Outcome Measures

Primary Outcomes (1)

• To assess the association of individual exposures (and their interaction) with the incidence of high-risk pregnancy.

  To assess the association of individual exposures (and their interaction) with the incidence of high-risk pregnancy.

  2022-2024

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants in the study will include all mother-child dyads classified as cases or controls who deliver at Fondazione Policlinico Gemelli (FPG). Out of 4,000 annual deliveries, an estimated 200 are classifiable as cases. Assuming a 70% response rate, it is anticipated that 140 cases and 280 controls will be enrolled per year, maintaining a 1:2 ratio. Enrollment will last for 24 months, with an expected total of 840 dyads. A missing rate of 20% is anticipated in the collection of biological samples due to lack of specific consent or logistical difficulties in obtaining samples at the time of enrollment.

You may qualify if:

• Being resident for at least two years in the city of Rome, Italy.
• Being assisted and giving birth at FPG (presumably referring to a specific hospital).
• Meeting the definition of case or control.
• Definitions:
• \- Cases:
• Women with single pregnancies diagnosed with late intrauterine growth restriction (≥32 weeks of gestational age), according to the definition of Gordjin et al., in the absence of structural and/or evident organ malformations.
• Women with spontaneous preterm birth at less than 32+0 weeks of gestational age.
• \- Controls:
• Full-term pregnant women (gestational age between 37+0 and 41+6 weeks) without intrauterine growth restriction or other structural and/or genetic disorders.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

Roma, Italia, 00168, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples will be collected from both mothers and newborns (including vaginal swab, placenta sample, blood, saliva, meconium, and bronchoalveolar lavage fluid) at birth and within the early hours of the newborn's life.

Central Study Contacts

Stefania Boccia

CONTACT

0630154396; stefania.Boccia@unicatt.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: September 27, 2024
• Study Start: September 15, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-04

Locations

IT (1)