motorische ontwikkeling Mental and Psychomotor development
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: All patients who were randomized in the ProTwin study (n
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean scores on the Bayley (mental and motor) scales. The mean scores of the Bayley in the general population is 100. A mean score below 92,5 (0,5 Standard Deviation, SD) is defined as clinically relevant. A sample size of 86 in each group (n=172) will have 90% power to detect a difference in means of 7,5 (the difference between a Group 1 mean of 100 and a Group 2 mean of 92,5 assuming that the common standard deviation is 15 using a two group t-test with a 0,05 two-sided significance level ß of 0.20. This means that a total of 69% should be reached in the follow-up and only 31% can be missed due to loss to follow-up or other reasons. | — |
Secondary
| Measure | Time frame |
|---|---|
| The scores in the ASQ, CBCL, general health status and maternal fertility questionnaires will be evaluated in secundary analyses. Comparison of the pessary group with the no-pessary group will be performed. For the ASQ questionnaire an abnormal score is a score of *2SD below the expected mean of a reference population. For the CBCL questionnaire for each scale, a strandardized T-score will be calculated. An abnormal T-score is a score at the >97 percentile. Scores on the general assessment questionnaire will be used for correction if there are relevant differences on the baseline characteristics. Univariate regression analysis will be performed to test the predictive value of a multiple antepartum variables on the neurodevelopmental and health related outcomes. Mortality Besides developmental outcomes we will register all children who died between the short term and long term follow-up. The possible difference in percentage will be tested for significance using Chi-square test. | — |
Countries
Netherlands
Outcome results
None listed