CDE Detailed Report

Record the date vital signs are taken. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Record the head circumference of the participant/ subject as well as the units for the measurement. Measurement must be done prior to any neurosurgical intervention and if there is soft tissue swelling it needs to be clearly noted that an enlarged Occipitofrontal circumference (OFC) due to STS is not the same as an enlarged OFC without STS. Abnormalities in OFC may identify children who were not neurologically normal at the time of injury in acute injury studies or serve as a baseline for following developmental outcome in studies with longer follow up.

Record the pulse of the participant/ subject in beats per minute. Record heart rate from monitor or by counting pulse rate. The suggested range is 0-300. Add date stamp for when assessed. Heart rate may be altered by trauma in a couple of ways. Tachycardia may indicate volume depletion, pain or stress, and higher heart rates have been found in patients that do not survive traumatic injuries. Bradycardia may be seen with elevated intracranial pressure. Pediatric-specific notes: As a minimum, vital signs should be recorded on admission and further, on a daily basis during the acute phase after injury. For the basic datasets, we recommend recording the average and lowest blood pressure over a given period. In the ICU environment, recording blood pressure on an hourly basis is recommended, especially when intracranial pressure (ICP) is monitored in order to permit determination of CPP, calculated as mean arterial blood pressure (MABP) – ICP (intermediate data set). Resting BP and HR should be obtained following empting of the bladder and 5 minutes of resting period. Both physical activities and full urinary bladder could affect these parameters.

Record the height (or length for the very young) of the participant/ subject. To be collected at the visit, not self-reported. Also, indicate whether height was measured in inches (in) or centimeters (cm). The suggested range is 0-500 cm or 0-100 inches. Height and weight can be measured or estimated upon admission, or alternatively information may be obtained from relatives. Add date stamp for when assessed. Documentation of height and weight is motivated by two reasons: 1. the risk of (systemic) complications is greater in the presence of obesity; 2. body weight is important for calculating required doses of (study) medications. For Headache: Completed by each member of your household who suffers from severe headaches.

Choose only one unit. Choose either Inches (in) or Centimeters (cm).

Record the temperature of the participant/ subject. Also indicate the scale used to capture temperature. Pediatric-specific notes: As a minimum, vital signs should be recorded on admission and further, on a daily basis during the acute phase after injury. For the basic datasets, we recommend recording the average and lowest blood pressure over a given period. In the ICU environment, recording blood pressure on an hourly basis is recommended, especially when intracranial pressure (ICP) is monitored in order to permit determination of CPP, calculated as mean arterial blood pressure (MABP) – ICP (intermediate data set).

Choose one. Record the location where the temperature was measured. This element is most relevant to pediatric clinical studies.