fAMily Integrated CAre in the neonatal ward: 5-year follow-up- the AMICA-5 study

fAMily Integrated CAre in the neonatal ward: 5-year follow-up- the AMICA-5 study - The AMICA-5 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51659

Enrollment

949

Registered

2022-07-05

Start date

2022-11-14

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Neonatal care

Interventions

n.a.

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Written informed consent to approach for follow-up study of the AMICA study.

Exclusion criteria

Exclusion criteria: No consent

Design outcomes

Primary

Measure	Time frame
The primary outcome for the children is cognitive development at 5.5 years of age as defined by the total score on the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (WPPSI-IV). The WPPSI-IV is an intelligence test designed for children aged 2 years 6 months to 7 years 7 months, performed by trained and certified psychologists. The primary outcome for the parents is parenting stress defined by the total score on the Parenting Stress Questionnaire (PSQ). The PSQ is a 34-items self-report measure that assesses among other things parental stress and parent-child bonding.	—

Measure

Time frame

The primary outcome for the children is cognitive development at 5.5 years of age as defined by the total score on the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (WPPSI-IV). The WPPSI-IV is an intelligence test designed for children aged 2 years 6 months to 7 years 7 months, performed by trained and certified psychologists. The primary outcome for the parents is parenting stress defined by the total score on the Parenting Stress Questionnaire (PSQ). The PSQ is a 34-items self-report measure that assesses among other things parental stress and parent-child bonding.

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Secondary

Measure	Time frame
Secondary outcome measures on the children are additional developmental outcomes behaviour (assessed with the CBCL), speech (assessed with VAI), social-emotional development (assessed with ASQ-SE)); growth (length/weight/BMI); and health-related quality of life (assessed with the PedsQL) at 5.5 years of age. Secondary outcomes for the parents are additional mental health outcomes as measured by depression and anxiety (assessed with PROMIS-AD); distress (assessed with DT-P); and posttraumatic stress (assessed with PCL-5) at 5.5 years of age.	—

Measure

Time frame

Secondary outcome measures on the children are additional developmental outcomes behaviour (assessed with the CBCL), speech (assessed with VAI), social-emotional development (assessed with ASQ-SE)); growth (length/weight/BMI); and health-related quality of life (assessed with the PedsQL) at 5.5 years of age. Secondary outcomes for the parents are additional mental health outcomes as measured by depression and anxiety (assessed with PROMIS-AD); distress (assessed with DT-P); and posttraumatic stress (assessed with PCL-5) at 5.5 years of age.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)