Early Life Anemia and Children's Risk of Neurodevelopmental Disorders: National and Regional Register-based Studies

Anemia Clinical Trial

Official title:

Early Life Anemia and Children's Risk of Neurodevelopmental Disorders: National and Regional Register-based Studies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06199362
• Other study ID #: VR2022-00592_1
• Secondary ID: DNR2010/1185-31/
• Status: Active, not recruiting
• Start date: August 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The overall project aim is to study children's 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 children's neurodevelopmental outcomes over the range of maternal hemoglobin levels during pregnancy.

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 (i.e., 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 infant's 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 children's diagnoses of any of three common neurodevelopmental conditions: autism, attention-deficit/hyperactivity 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 (e.g., autism with co-occurring intellectual disability).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2400000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• children born in Sweden from January 1, 1987 to December 31, 2010 (national cohort)
• children born in Region Stockholm from January 1, 2007 to December 31, 2010 (Stockholm regional cohort)

Exclusion Criteria:

• Adopted children
• Children without records in the Medical Birth Registry (MBR)

Related Conditions & MeSH terms

• ADHD
• Anemia
• Autism
• Intellectual Disability
• Neurodevelopmental Disorders

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autism	ICD-9: 299; ICD-10: F84	Children's diagnoses of autism, with follow up beginning at 2 years of age.
Primary	ADHD	ICD-9: 314; ICD-10: F90; supplemented with methylphenidate [N06BA04] or atomoxetin [N06BA09] prescriptions registered in the Swedish Prescribed Drug Register	Children's diagnoses of ADHD, with follow up beginning at 2 years of age.
Primary	Intellectual Disability	ICD-9: 317-319 ICD-10: F70-F79	Children's diagnoses of intellectual disability, with follow up beginning at 2 years of age.
Primary	Any Neurodevelopmental Condition	Any diagnosis of Autism, ADHD, or Intellectual Disability	Children's diagnoses of neurodevelopmental conditions, with follow up beginning at 2 years of age.
Secondary	Autism with Intellectual Disability	Diagnosis of both autism and intellectual disability during the follow-up period.	Children's diagnoses, with follow up beginning at 2 years of age.
Secondary	Autism with ADHD	Diagnosis of both autism and ADHD during the follow-up period.	Children's diagnoses, with follow up beginning at 2 years of age.
Secondary	Autism without co-morbidities (ADHD or ID)	Diagnosis of autism without a diagnosis of ADHD or intellectual disability during the follow-up period.	Children's diagnoses, with follow up beginning at 2 years of age.
Secondary	ADHD without co-morbidities (ID or Autism)	Diagnosis of ADHD without a diagnosis of autism or intellectual disability during the follow-up period.	Children's diagnoses, with follow up beginning at 2 years of age.
Secondary	Intellectual Disability without Autism	Diagnosis of intellectual disability without a diagnosis of autism during the follow-up period.	Children's diagnoses, with follow up beginning at 2 years of age.