Table 11: Live born neonatal/infant outcome details

The following CDE items should be collected for each live born infant from the reported pregnancy.


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
Complications in the first year of life Any complication experienced in the first year of life Value 1 - Options: a) Yes, b) No, c) Unknown

If "Yes", Value 2 (MedDRA/ICD diagnosis code): Text

If "Yes", Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text

Value 4 (record additional details of the complication not covered by the coding system): Text

Value 5 (did the complication occur in the neonatal period) - Options: a) Yes, b) No, c) Unknown
Yes Yes Directly reported Report statistics Note that this element should contain data relating to neonatal complications (complications arising from birth until the end of 27th day after birth, i.e. first 28 days of life).
Postnatal death of live born infant Details of the death of a live born infant Value 1 - Options: a) Yes, b) No, c) Unknown

If "Yes", Value 2 (date of death): Date (dd/mmm/yyyy)



If "Yes", Value 3 (MedDRA/ICD cause of death code): Text

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

Value 5 (record additional details of the complication not covered by the coding system): Text

Values 6 (age at death category) - Options: a) Infant death, b) Child death, c) Unknown

If "Infant death", Values 7 (neonatal death) - Options: a) Yes, b) No, c) Unknown
Yes Yes Directly reported Report statistics

Follow-up
Age at death categories include infant death where the offspring dies in the first year after birth, or childhood death where the offspring dies beyond the first year after birth.

Neonatal deaths are a sub-category of infant death where the offspring dies after birth but before the end of 27th day after birth, i.e. within the first 28 days of life.

It is recommended to record age at death in days for children <1 month old, record in months for children <2 years old and years in children ≥2 years.

Post-mortem details should be recorded where available.
Product/disease-specific outcomes Offspring outcomes specific to the investigated medicinal product Value 1 - Options: a) Yes, b) No

If "Yes", Value 2 (MedDRA/ICD diagnosis code): Text

If "Yes", Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text

Value 4 (record additional details of the complication not covered by the coding system): Text

Values 5 (age at diagnosis): Integer
Yes* Yes* Directly reported Report statistics *Only essential these details are collected when these outcomes are to be described in the study report statistics.

Examples may include measures of immune function in the offspring of those exposed to immunosuppressant in utero.