Table 13: Longer-term child health outcome details

It is recognised that not all child longer-term outcomes will be able to be covered by a single study but the domains listed here should be covered by a set of complementary studies, which together build up a comprehensive evidence-base. It is also noted that individual measurements of offspring health and development will not be sufficient to detect nor exclude associations between in utero medication exposure and adverse health or neurodevelopmental outcomes; rather data should be collected regularly throughout childhood.


Display only CDE items recommended as ESSENTIAL when studying: Pregnancy and infant outcomes Longer term childhood outcomes

CDE Item Definition Recommended data format and suggested values Essential to collect when studying pregnancy and infant outcomes Essential to collect when studying longer term childhood outcomes Source Purpose Notes
Infant/child medical problems Has the infant/child had any medical problems since birth. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Values 2 (date of diagnosis): Date (dd/mmm/yyyy)

Value 3 (MedDRA/ICD diagnosis code): Text

Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail): Text

Value 5 (additional relevant details not covered by coding system): Text
Yes Yes Directly reported Report statistics These details should be recorded for every medical problem experienced during infancy or childhood.

Child health is very complex and numerous conditions may present. For the purposes of the CDE recommendations, it was not considered practical to include a listing of all possible conditions. If researchers are aware of any specific conditions related to either an exposure or outcome of interest, these should also be included specifically. There may also be benefit in including detail on condition severity.
Infant/child specialist visit Has the child required any specialist reviews? Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 - Options: a) Paediatrician, b) Nutritionist, c) Clinical Geneticist, d) Ophthalmologist, e) Child Development Centre, f) Audiologist, g) Physiotherapist, h) Speech Therapist, i) Occupational Therapist, j) Psychologist, k) Neurologist, l) Other

If Other, Value 3 (details): Text
Yes Yes There are considerable international variations in healthcare utilisation practices. In some countries, access to a specialist may be routine, whereas in others, specialist review may be reserved for more severe conditions. As such, there may be variation in the suitability of this data variable to identify signals of infant/childhood health or neurodevelopmental concerns. In countries where routine specialist access is observed, researchers may wish to limit the collection of this data element to non-standard clinical interactions (if possible). Report statistics
Infant/child medication Child medication use. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (medication name): Text

Value 3 (ATC code): Text

Value 4 (indication): Text

Value 5 (MedDRA/ICD diagnosis code): Text

Value 6 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) – Text

Value 7 (date started): Date (dd/mm/yyyy)

Value 8 (date stopped if applicable): Date (dd/mm/yyyy)
Yes Yes Directly reported Report statistics

Risk factor
Infant/child professional concerns Report of any developmental concerns raised by professionals. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (details): Text
Yes Yes Directly reported Report statistics It may be educational or health professional who raise concerns.
Infant/child vision difficulties Difficulties with child vision. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (details): Text

Value 3 (MedDRA/ICD diagnosis code): Text

Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) – Text

Value 5 (difficulties confirmed by an eye test) - Options: a) Yes, b) No, c) Unknown
Yes Yes Directly Reported Report statistics
Infant/child hearing difficulties Difficulties with child hearing. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (details): Text

Value 3 (MedDRA/ICD diagnosis code): Text

Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) – Text

Value 5 (difficulties confirmed by a hearing test) - Options: a) Yes, b) No, c) Unknown
Yes Yes Directly Reported Report statistics
Infant/child toileting difficulties Does the child have any frequent difficulties with the passing of urine or opening of their bowels? Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (details): Text

Value 3 (MedDRA/ICD diagnosis code): Text

Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) – Text
Yes Yes Directly Reported Report statistics
Infant/child eczema/ skin conditions Diagnosis of eczema or other skin conditions. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (details): Text

Value 3 (MedDRA/ICD diagnosis code): Text

Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) – Text

Value 5 (details of any investigations): Text
Yes Yes Directly Reported Report statistics
Infant/child asthma/ respiratory conditions Diagnosis of asthma or other respiratory conditions. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (details): Text

Value 3 (MedDRA/ICD diagnosis code): Text

Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) – Text

Value 5 (details of any investigations): Text
Yes Yes Directly Reported Report statistics
Infant/child congenital heart disease Diagnosis of congenital heart disease. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (details): Text

Value 3 (MedDRA/ICD diagnosis code): Text

Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) – Text

Value 5 (details of any investigations): Text
Yes Yes Directly Reported Report statistics
Infant/child food allergies Diagnosis of food allergies. Value 1 - Options: a) Yes, b) No, c) Unknown

If Yes, Value 2 (details): Text

Value 3 (MedDRA/ICD diagnosis code): Text

Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) – Text

Value 5 (details of any investigations): Text
Yes Yes Directly Reported Report statistics