Post-intensive care syndrome in children Other
Conditions
Interventions
This is a long-term follow-up study of former critically ill children who had been included in the large, multicentre PEPaNIC randomised controlled trial on the impact of early versus late initiation
Sponsors
Universitair Ziekenhuis Leuven
Eligibility
Sex/Gender
All
Age
12 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1. Participated in the PEPaNIC trial as a critically ill patient or having been recruited as a healthy child within the control group for a longitudinal follow-up in parallel with the PEPaNIC patients 2. Survival up to the 12-year follow-up time point
Exclusion criteria
Exclusion criteria: No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical assessment of growth (measured height and body weight, calculated BMI, total body fat mass and total body muscle mass as measured via dual-energy X-ray absorption [DEXA] scan) at 12-year follow-up 2. The developmental stage of puberty at 12-year follow-up, as based on interrogation of Tanner stages with the use of a sex-specific questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| All outcomes are measured at the 12-year follow-up: 1. Health status: diagnosis of a somatic illness, diagnosis of a psychiatric illness, and incidence of hospital admission for medical, surgical or psychiatric reasons during the past 12 years for participants in the control group or during the 12 years following admission to the PICU for PEPaNIC participants. Measured by a structured interview with the parents or caregivers, and/or the participants if competent and old enough. 2. Additional measures of physical growth: measurement of leg length and sitting height, and calculation of the proportion of leg length over total height and sitting height ratio at 12-year follow-up. 3. Additional measures of body composition: 3.1. Total bone mass and localised (arms, legs, and trunk) bone mass, fat mass and lean tissue mass measured via dual-energy X-ray absorption (DEXA) scan at 12-year follow-up 3.2. Surrogate markers of body composition (waist circumference as a measure of central adiposity/obesity, skinfold thickness as a measure of subcutaneous body fat at the triceps and subscapular level (allowing estimation of body fat with the use of the Slaughter equation), a combination of mid-upper arm circumference and triceps skinfold as a marker of muscle mass. 4. Additional measures of pubertal and further development: With the use of sex-specific questionnaires on pubertal development also interrogates other aspects of puberty development and the time of reaching specific a priori defined stages: 4.1. Development of axillary hair 4.2. Acne 4.3. Menarche 4.4. Growth of facial hair 4.5. First ejaculation of semen 4.6. Voice break 5. During the interrogation of medical history related to the occurrence of somatic illness or hospital admission, health conditions or previous therapies will be documented, including those that may interfere with pubertal development. 6. Where possible, the researchers also aim to evaluate the next crucial developmental stage going in the | — |
Countries
Belgium, Netherlands
Contacts
Public ContactGreet Van den Berghe
Outcome results
None listed