The PEPaNIC long-term outcome study: Post-Intensive Care Syndrome in children (PICS-p);long-term harm extending into puberty, adolescence and young adulthood

The PEPaNIC long-term outcome study: Post-Intensive Care Syndrome in children (PICS-p);long-term harm extending into puberty, adolescence and young adulthood - PICS-pub

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57746

Enrollment

500

Registered

2025-06-24

Start date

2025-08-07

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kinderen die kritiek ziek zijn geweest en behandeld op Intensive Care Critical illness / malnutrition

Interventions

None listed

Eligibility

Age

12 Years to 64 Years

Inclusion criteria

Inclusion criteria: The children who are participants in the PEPaNIC study are all eligible for the long-term outcome study. Healthy controls, were recruited for an identical 2 and 4-years follow-uo program, they are now also invited to join the 12 years follow-up.

Exclusion criteria

Exclusion criteria: No exclusion criteria, other than 'no consent', are applicable for the PEPaNIC patients. The exclusion criteria for the healthy controls were: • History of neonatal or paediatric intensive care admission • History of parenteral nutrition • Incapacity of will, non testable participants or not possible to complete questionaires

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the 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). In addition, as a potential mediator of impact on growth, we will assess developmental stage of puberty at 12-year follow-up, as based on interrogation of Tanner stage for pubic hair (P1-5) and breast development (B1-5) for female participants or Tanner stage for pubic hair (P1-5) and genital development (G1-5) for male participants, with use of a sex-specific questionnaire.	—

Measure

Time frame

The primary endpoint is the 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). In addition, as a potential mediator of impact on growth, we will assess developmental stage of puberty at 12-year follow-up, as based on interrogation of Tanner stage for pubic hair (P1-5) and breast development (B1-5) for female participants or Tanner stage for pubic hair (P1-5) and genital development (G1-5) for male participants, with use of a sex-specific questionnaire.

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Secondary

Measure	Time frame
Health Status Additional Measures of Physical Growth Additional Body Composition Measurements Additional measures of pubertal and further development Bone Age Cardiometabolic Risk Factors Physical activity Neurocognitive function Emotional and behavioral problems Impact on daily life Collection of biological samples	—

Countries

Netherlands

Outcome results