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The resilient brain of preterm born children

The resilient brain of preterm born children - RESPROUT study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48425
Enrollment
160
Registered
2019-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Hersenactiviteit na acute stress. Stress-related brain acitivity

Interventions

Participants are randomly assigned to either a stress condition or a control condition of the Trier Social Stress Test for Children (TSST-C
Buske-Kirschbaum et al., 1997): - healthy term-born children-non-stress (n=25) - healthy term-born children-stress (n=25) - preterm born children-non-stress (n=25) - preterm born children-stress (n=85

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Extremely preterm born children - Gestational age 38 weeks - Age and gender at assessment are matched to an extremely preterm born child included in the study.

Exclusion criteria

Exclusion criteria: Extremely preterm born children - Major chromosomal and/or congenital anomalies. - Current psychiatric disorder (i.e., as indicated by a current DSM-V diagnosis) - Ferromagnetic objects inside the body (see MRI screening) - Claustrophobia - Use of medication known to influence HPA-axis functioning (i.e., corticosteroid medication) - Parents are not willing to provide informed consent - Parents are not allowing unexpected findings to be reported to themselves or their general practitioner(s)., Healthy controls In addition to the previously mentioned exclusion criteria for preterm born children, the following criteria will disqualify prospective control participants from participating: - Relative of the included preterm born child. *

Design outcomes

Primary

MeasureTime frame
- Brain activity measured with fMRI during emotion processing (i.e., IAPS), behavioural control (i.e., SSAT), and rest, following acute stress in premature born children compared to full-term born children. - Factors determining variability underlying brain activity following acute stress in extremely preterm born children, such as coping strategies, life events, and personality, amongst others.

Secondary

MeasureTime frame
To study basal and stress-induced changes in hormonal levels (i.e., cortisol, alpha-amalyse), heart-rate, and perceived stress (i.e., VAS) in preterm born children compared to healthy controls.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)