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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37610
Enrollment
60
Registered
2012-12-20
Start date
2013-03-13
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

prematuur geboren kinderen preterm born children very low birth weight children

Interventions

The additional intervention will follow the same steps and approaches of the ToP rogramme, but will be implemented during play and daily activities suitable for children from approximately 18 to 22
2) When the child shows self-regulatory efforts to concentrate, cope, or console, parents are encouraged to give verbal, visual, or physical support to their child*s own self-regulating strategies
or parents may adapt the environment when their child*s efforts are at the cost of their energy and protect their child from interference when engaged in a focused activity
3) When the child shows signs of disorganization or non-engagement, parents are encouraged to adapt the timing, intensity or complexity of the environmental information to protect their child from s

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Very preterm born childeren: GA

Exclusion criteria

Exclusion criteria: No sufficient knowledge of Dutch language and no interpretator available.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)