Development and evaluation of the feasibility of an ageappropriate additional, preventive intervention for very preterm children at 18 months.

Completed

• Conditions: prematuur geboren kinderen; preterm born children; very low birth weight children

• Registration Number: NL-OMON37610
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Very preterm born childeren: GA < 32 weeks and/or birth weight < 1500 gr, and participated in the early intervention ToP programme

Exclusion Criteria

No sufficient knowledge of Dutch language and no interpretator available.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> For this pilot study, the process evaluation for the feasibility of the<br /><br>additional intervention includes the number of parents and children that<br /><br>participate in the study and in the intervention, the reasons for not complying<br /><br>with the intervention, the number of home visits per child, the duration and<br /><br>content of the home visits and parental satisfaction with the intervention. In<br /><br>addition, the feasibility of the assessments that we want to include in a RCT<br /><br>includes the number of completed assessments and returned questionnaires,<br /><br>missing data and reasons for not participating in the assessments or not<br /><br>returning questionnaires. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameter, used to obtain information on the effect size of the<br /><br>additional intervention: the Lexilist for receptive language, the Ages and<br /><br>Stages Questionnaire (ASQ), the Infant Toddler Social and Emotional Assessment<br /><br>(ITSEA), the motor and cognitive scales of the Bayley Scales of Infant and<br /><br>Toddler Development, third edition (BSID-III), and the Emotional Availability<br /><br>Scales (EAS). </p><br>