Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199362
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-29
Brief Title:
Early Life Anemia and Childrens Risk of Neurodevelopmental Disorders National and Regional Register-based Studies
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Early Life Anemia and Childrens Risk of Neurodevelopmental Disorders National and Regional Register-based Studies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall project aim is to study childrens neurodevelopmental outcomes including diagnoses of autism ADHD and intellectual disability following exposure to maternal anemia during pregnancy or anemia during the first year of life using national and regional Swedish health-data registers and to assess childrens neurodevelopmental outcomes over the range of maternal hemoglobin levels during pregnancy
Detailed Description:
Our overall hypothesis is that early life iron sufficiency may promote appropriate neurodevelopment and reduce risk of neurodevelopmental disorders in children We will use Swedish register data to define a cohort of maternal-child pairs to follow from gestation through childhood We will consider exposure to anemia during two key time periods gestation and the first year of life Exposure data are recorded in Swedish medical records prospectively relative to the follow-up for the outcomes
To assess exposure to maternal anemia we will consider maternal diagnoses of anemia during pregnancy in a national cohort of maternal-child pairs using ICD codes recorded in pregnancy in the Swedish National Patient Register and the Swedish Medical Birth Register In a sub-sample of mother-child pairs in Stockholm with data available from antenatal records ie Obstetrix register data we will also collect data regarding levels of maternal hemoglobin measured longitudinally over the course of pregnancy and consider this as a continuous variable and divided into categories to reflect the full range of potential exposures from very low to very high We will consider whether risk of the outcomes associated with exposure to anemia or decreasing hemoglobin levels vary with the time of onset during pregnancy
To assess exposure to anemia during the first year of life we will consider infants diagnoses of anemia during the first year of life in a national cohort of maternal-child pairs using ICD codes recorded during the year after birth in the Swedish National Patient Register We will consider whether risk of the outcomes associated with exposure to anemia during vary with the time of onset during the first year of life and whether anemia during the first year interacts with gestational age at birth
The main outcome measures will be incidence of childrens diagnoses of any of three common neurodevelopmental conditions autism attention-deficithyperactivity disorder ADHD and intellectual disability Diagnoses will be ascertained using ICD codes recorded in pregnancy in the Swedish National Patient Register For the sub-sample of mother-child pairs for children born in Stockholm we will also ascertain outcomes in regional registers that capture further sources of outpatient treatment and care primarily the VAL database Secondary analyses will consider the incidence of commonly co-occurring combinations of the disorders eg autism with co-occurring intellectual disability
To assess exposure to maternal anemia we will consider maternal diagnoses of anemia during pregnancy in a national cohort of maternal-child pairs using ICD codes recorded in pregnancy in the Swedish National Patient Register and the Swedish Medical Birth Register In a sub-sample of mother-child pairs in Stockholm with data available from antenatal records ie Obstetrix register data we will also collect data regarding levels of maternal hemoglobin measured longitudinally over the course of pregnancy and consider this as a continuous variable and divided into categories to reflect the full range of potential exposures from very low to very high We will consider whether risk of the outcomes associated with exposure to anemia or decreasing hemoglobin levels vary with the time of onset during pregnancy
To assess exposure to anemia during the first year of life we will consider infants diagnoses of anemia during the first year of life in a national cohort of maternal-child pairs using ICD codes recorded during the year after birth in the Swedish National Patient Register We will consider whether risk of the outcomes associated with exposure to anemia during vary with the time of onset during the first year of life and whether anemia during the first year interacts with gestational age at birth
The main outcome measures will be incidence of childrens diagnoses of any of three common neurodevelopmental conditions autism attention-deficithyperactivity disorder ADHD and intellectual disability Diagnoses will be ascertained using ICD codes recorded in pregnancy in the Swedish National Patient Register For the sub-sample of mother-child pairs for children born in Stockholm we will also ascertain outcomes in regional registers that capture further sources of outpatient treatment and care primarily the VAL database Secondary analyses will consider the incidence of commonly co-occurring combinations of the disorders eg autism with co-occurring intellectual disability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DNR20101185-315 | OTHER | Stockholm Regional Ethical Committee | None |