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. |