Early Childhood, NeurodevelopmentIoMumNEXTNCT06226311
Environmental Pollutants in Pregnancy - IoMumNEXT
An observational study of Early Childhood, Neurodevelopment and Early Childhood, Anthropometry, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Globally 12.6 million people, including 1.7 million children under the age of 5, die each year from environmental-related illnesses. Prenatal exposure to environmental chemical pollutants has been associated with perinatal mortality, prematurity, low birth weight, congenital malformations, neurobehavioral function… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood, Neurodevelopment, Early Childhood, Anthropometry
- What is being tested?
- Data collection and Diagnostic Test: Urinary
- How many people
- 450 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will be based on the 1155 pregnant women from the IoMum cohort, who have already been recruited at the Centro Hospitalar Universitário de São João (CHUSJ) and at CUF Descobertas Hospital (CUFD), Lisbon, in the 1st trimester ultrasound scan, as well as by the children born in this cohort.
Who may be able to join
- Have had single live birth
- Have provided contact and a urine sample T1
- Have provided consent to participate at T1
- Have provided consent to participate at T3
Who cannot join
- Pregnancy complications
- Congenital malformations
- Gestational diabetes
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Medicine (FMUP)
Porto, 4200-319
Elisa Keating, PhD, (+351) 225513624, keating@med.up.pt
About this study
Official title: Environmental Pollutants in Pregnancy - Exposure Assessment and Association With Early Childhood Development - IoMumNEXT
Globally 12.6 million people, including 1.7 million children under the age of 5, die each year from environmental-related illnesses. Prenatal exposure to environmental chemical pollutants has been associated with perinatal mortality, prematurity, low birth weight, congenital malformations, neurobehavioral function disorder and metabolic disorders. This project aims: a) to evaluate exposure to environmental pollutants during pregnancy; and, b) to study the association of this exposure with anthropometry and neurodevelopment of the offspring, up to 6 years of age. This study will be based on a population of 1000 pregnant women whose recruitment has already started under the IoMum project (clinical trials #NCT04010708), previously approved by Ethics Commitee of Centro Hospitalar e Universitário São João/Faculdade de Medicina da Universidade do Porto (#292-17). Maternal urine samples collected in the 1st and 3rd trimesters of pregnancy will be used. Maternal urinary concentrations of toxic metals and pesticide metabolites will be determined and neurodevelopmental outcomes will be evaluated as well as anthropometric parameters of children from birth to 6 years of age. The results of this project will contribute to the characterization of the exposure of Portuguese pregnant women to environmental pollutants as well as to the knowledge on the association between isolated or cumulative exposure to these pollutants and the health of the offspring.
Read the detailed description
IoMumNEXT is a prospective observational study which will take advantage of our previous IoMum project - monitoring of iodine status in Portuguese pregnant women: impact of supplementation (Clinical Trials record: NCT04010708), a prospective observational study that has set up a cohort of 1155 pregnant women, living in the Porto and Lisbon Metropolitan Areas.
In a subsample of 199 pregnant women of this IoMum@Porto cohort it was already possible to conclude that:
- 19 and 32% of women had urinary levels (first trimester) of lead (208Pb) and arsenic (75As), respectively above the corresponding reference values (> 4 microg / L for Pb and> 35 microg / L for As).
- Maternal urinary Pb levels (first trimester) revealed a positive association with birth weight and length.
- Maternal urinary levels of As (first trimester) revealed a positive association with head circumference at birth.
- In a subsample of 69 pregnant women, 52% showed urinary 3-Phenoxybenzoic acid (3-PBA) levels above the detection level.
In addition to Pb, As and 3-PBA, the maternal urinary concentrations of other pollutants such as the elements lithium (7Li), cadmium (111Cd) and mercury (80Hg), and the pesticide metabolite trichloro-pyridinol (TCPY) will be analyzed. The continuity of this work will allow an important scientific advance, regarding the association between exposure to environmental pollutants and the physical and neurobehavioral development of children.
This proposal is in line with goal 3 (Health and well-being) of the United Nations Agenda 2030.
The study population will be composed of the pregnant women from the IoMum cohort as well as by their children born from this cohort. Maternal urine samples collected in the first trimester (T1) and third trimesters (T2) of pregnancy will be used, as well as urine samples from children collected between 3 and 6 years of age. Sociodemographic, lifestyle, anthropometric and health data will continue to be collected between 3 and 4 years of age (T3) and between 5 and 6 years of age (T4). Additionally, neurodevelopment will be assessed by Vineland adaptative behaviour scale at T3 and T4.
- Being tested
- Data collection, Diagnostic Test: Urinary
- Keywords
- Pregnancy, Childhood, Exposure, Environmental Pollutants, Anthropometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Collection of sociodemographic, lifestyle and health data; Child anthropometry (weight, height and head circumference) at the ages of 3-4 and 5-6 years Child neurodevelopment scores at the ages of 3-4 and 5-6 years
Diagnostic Test: UrinaryOther
Trichloro-pyridinol (TCPy) and 3-phenoxybenzoic acid (3-PBA) Environemental oligoelements including Lithium (7Li), Arsenic (75As), Cadmium (111Cd), Lead (208Pb) and Mercury (80Hg)
| Study group | Role | What they receive |
|---|---|---|
| Children of IoMum pregnants cohort | IoMum participants without congenital malformations or gestational diabetes, with a singleton pregnancy with live birth, who provided contact and a T1 urine sample, will be invited to participate under signed informed consent. Receives: Other: Data collection; Other: Diagnostic Test: Urinary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements of children - Weight
Information n the weight (in kilograms) of children aged between 3-4 and 5-6 years will be recorded
Measured: The information will be collected at baseline by telephone contact (3-4 years of age) with parents or legal representatives or by direct, in person, measurement (5-6 years of age)
Anthropometric measurements of children - Height
Information on the height (in centimeters) of children aged between 3-4 and 5-6 years will be recorded
Measured: The information will be at baseline collected by telephone contact (3-4 years of age) with parents or legal representatives or by direct, in person, measurement (5-6 years of age)
Neurodevelopment scores of children
Communication, daily life activities, socialization and motor skills will be assessed using the Vineland Adaptive Behavior Scale
Measured: At 3-4 and 5-6 years old of the children, parents will answer a questionnaire regarding daily living, social, communication and motor skills adjusetd to the specific age group, at baseline
1st trimester maternal urinary concentrations of environmental pollutants
Median urinary concentations of 3-PBA, TCPY in micrograms per liter
Measured: Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
1st trimester maternal urinary concentrations of oligoelements
Median urinary concentations of Pb, As, Cd, Li, Hg in micrograms per liter
Measured: Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
Secondary outcomes (7)
1st trimester maternal urinary concentration of iodine
Median urinary iodine concentrations at 1st trimester of gestation, in micrograms per liter
Measured: Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
3rd trimester maternal urinary concentration of environmental pollutants
Median urinary concentations of 3-PBA, TCPY, in micrograms per liter
Measured: Between gestational weeks 37 and 40 plus 6 days (Timepoint 2)
3rd trimester maternal urinary concentration of oligoelements
Median urinary concentations of oligoelements including Pb, As, Cd, Li, Hg, in micrograms per liter
Measured: Between gestational weeks 37 and 40 plus 6 days (Timepoint 2)
Anthropometric measures of the children at birth, 1, 2 and 4 years - Weight
Weight information in grams or kilograms will be collected retrospectively from the clinical records or reported by the parents
Measured: Birth, 1, 2 and 4 years of age (retrospectively collected at the same moment, during the first phone call)
Anthropometric measures of the children at birth, 1, 2 and 4 years - Height
Stature information in centimeters will be collected retrospectively from the clinical records or reported by the parents
Measured: Birth, 1, 2 and 4 years of age (retrospectively collected at the same moment, during the first phone call)
Anthropometric measures of the children at birth, 1 and 2 years - Head circumference
Head circumference in centimeters will be collected retrospectively from the clinical records or reported by the parents
Measured: Birth, 1 and 2 years of age (retrospectively collected at the same moment, during the first phone call)
Apgar index
Apgar index at 1, 5 and 10 minutes
Measured: Birth (retrospectively collected)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood, NeurodevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Responsible party
- Sponsor
- Investigators
- Elisa Keating, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226311
- Sponsor's protocol ID
- IoMumNEXT
- Acronym
- IoMumNEXT
- Status last verified
- Oct 2023
- First submitted
- 6 Dec 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Pollutants in Pregnancy - Exposure Assessment and Association With Early Childhood Development - IoMumNEXT
- ClinicalTrials.gov ID
- NCT06226311
- Acronym / sponsor ID
- IoMumNEXT / IoMumNEXT
- Keywords
- Pregnancy, Childhood, Exposure, Environmental Pollutants, Anthropometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Globally 12.6 million people, including 1.7 million children under the age of 5, die each year from environmental-related illnesses. Prenatal exposure to environmental chemical pollutants has been associated with perinatal mortality, prematurity, low birth weight, congenital malformations, neurobehavioral function disorder and metabolic disorders. This project aims: a) to evaluate exposure to environmental pollutants during pregnancy; and, b) to study the association of this exposure with anthropometry and neurodevelopment of the offspring, up to 6 years of age. This study will be based on a population of 1000 pregnant women whose recruitment has already started under the IoMum project (clinical trials #NCT04010708), previously approved by Ethics Commitee of Centro Hospitalar e Universitário São João/Faculdade de Medicina da Universidade do Porto (#292-17). Maternal urine samples collected in the 1st and 3rd trimesters of pregnancy will be used. Maternal urinary concentrations of toxic metals and pesticide metabolites will be determined and neurodevelopmental outcomes will be evaluated as well as anthropometric parameters of children from birth to 6 years of age. The results of this project will contribute to the characterization of the exposure of Portuguese pregnant women to environmental pollutants as well as to the knowledge on the association between isolated or cumulative exposure to these pollutants and the health of the offspring.
Detailed description
IoMumNEXT is a prospective observational study which will take advantage of our previous IoMum project - monitoring of iodine status in Portuguese pregnant women: impact of supplementation (Clinical Trials record: NCT04010708), a prospective observational study that has set up a cohort of 1155 pregnant women, living in the Porto and Lisbon Metropolitan Areas.
In a subsample of 199 pregnant women of this IoMum@Porto cohort it was already possible to conclude that:
- 19 and 32% of women had urinary levels (first trimester) of lead (208Pb) and arsenic (75As), respectively above the corresponding reference values (> 4 microg / L for Pb and> 35 microg / L for As).
- Maternal urinary Pb levels (first trimester) revealed a positive association with birth weight and length.
- Maternal urinary levels of As (first trimester) revealed a positive association with head circumference at birth.
- In a subsample of 69 pregnant women, 52% showed urinary 3-Phenoxybenzoic acid (3-PBA) levels above the detection level.
In addition to Pb, As and 3-PBA, the maternal urinary concentrations of other pollutants such as the elements lithium (7Li), cadmium (111Cd) and mercury (80Hg), and the pesticide metabolite trichloro-pyridinol (TCPY) will be analyzed. The continuity of this work will allow an important scientific advance, regarding the association between exposure to environmental pollutants and the physical and neurobehavioral development of children.
This proposal is in line with goal 3 (Health and well-being) of the United Nations Agenda 2030.
The study population will be composed of the pregnant women from the IoMum cohort as well as by their children born from this cohort. Maternal urine samples collected in the first trimester (T1) and third trimesters (T2) of pregnancy will be used, as well as urine samples from children collected between 3 and 6 years of age. Sociodemographic, lifestyle, anthropometric and health data will continue to be collected between 3 and 4 years of age (T3) and between 5 and 6 years of age (T4). Additionally, neurodevelopment will be assessed by Vineland adaptative behaviour scale at T3 and T4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children of IoMum pregnants cohort | – | Other: Data collection, Other: Diagnostic Test: UrinaryIoMum participants without congenital malformations or gestational diabetes, with a singleton pregnancy with live birth, who provided contact and a T1 urine sample, will be invited to participate under signed informed consent. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will be based on the 1155 pregnant women from the IoMum cohort, who have already been recruited at the Centro Hospitalar Universitário de São João (CHUSJ) and at CUF Descobertas Hospital (CUFD), Lisbon, in the 1st trimester ultrasound scan, as well as by the children born in this cohort.
Key inclusion criteria (4 listed)
- Have had single live birth
- Have provided contact and a urine sample T1
- Have provided consent to participate at T1
- Have provided consent to participate at T3
Key exclusion criteria (3 listed)
- Pregnancy complications
- Congenital malformations
- Gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionCollection of sociodemographic, lifestyle and health data; Child anthropometry (weight, height and head circumference) at the ages of 3-4 and 5-6 years Child neurodevelopment scores at the ages of 3-4 and 5-6 years | Other | Children of IoMum pregnants cohort |
| Diagnostic Test: UrinaryTrichloro-pyridinol (TCPy) and 3-phenoxybenzoic acid (3-PBA) Environemental oligoelements including Lithium (7Li), Arsenic (75As), Cadmium (111Cd), Lead (208Pb) and Mercury (80Hg) | Other | Children of IoMum pregnants cohort |
Primary outcome
Anthropometric measurements of children - Weight
Time frame: The information will be collected at baseline by telephone contact (3-4 years of age) with parents or legal representatives or by direct, in person, measurement (5-6 years of age)
Information n the weight (in kilograms) of children aged between 3-4 and 5-6 years will be recorded
Anthropometric measurements of children - Height
Time frame: The information will be at baseline collected by telephone contact (3-4 years of age) with parents or legal representatives or by direct, in person, measurement (5-6 years of age)
Information on the height (in centimeters) of children aged between 3-4 and 5-6 years will be recorded
Neurodevelopment scores of children
Time frame: At 3-4 and 5-6 years old of the children, parents will answer a questionnaire regarding daily living, social, communication and motor skills adjusetd to the specific age group, at baseline
Communication, daily life activities, socialization and motor skills will be assessed using the Vineland Adaptive Behavior Scale
1st trimester maternal urinary concentrations of environmental pollutants
Time frame: Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
Median urinary concentations of 3-PBA, TCPY in micrograms per liter
1st trimester maternal urinary concentrations of oligoelements
Time frame: Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
Median urinary concentations of Pb, As, Cd, Li, Hg in micrograms per liter
7 secondary outcomes
1st trimester maternal urinary concentration of iodine
Time frame: Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
3rd trimester maternal urinary concentration of environmental pollutants
Time frame: Between gestational weeks 37 and 40 plus 6 days (Timepoint 2)
3rd trimester maternal urinary concentration of oligoelements
Time frame: Between gestational weeks 37 and 40 plus 6 days (Timepoint 2)
Anthropometric measures of the children at birth, 1, 2 and 4 years - Weight
Time frame: Birth, 1, 2 and 4 years of age (retrospectively collected at the same moment, during the first phone call)
Anthropometric measures of the children at birth, 1, 2 and 4 years - Height
Time frame: Birth, 1, 2 and 4 years of age (retrospectively collected at the same moment, during the first phone call)
Anthropometric measures of the children at birth, 1 and 2 years - Head circumference
Time frame: Birth, 1 and 2 years of age (retrospectively collected at the same moment, during the first phone call)
Apgar index
Time frame: Birth (retrospectively collected)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Keating, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Childhood, Neurodevelopment and Early Childhood, Anthropometry, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Keating, PhD ((+351) 225513624, keating@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements of children - Weight (time frame: The information will be collected at baseline by telephone contact (3-4 years of age) with parents or legal representatives or by direct, in person, measurement (5-6 years of age)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.