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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The objective of this randomized study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of Infant Development-II (BSID-II) in the same group of infants who were born very preterm.
The objective of this randomized crossover study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III are higher than scores on the Bayley Scales of Infant Development-II in the same group of infants who were born very preterm. First, however, the investigators must demonstrate that significant "learning" does not occur when the tests are administered 4-8 weeks apart. The investigators hypothesize that scores on the Bayley-III will be higher than scores on the BSID-II, irrespective of the order in which the tests are administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSID-II, then Bayley-III | Active Comparator | Receive BSID-II testing 4-8 weeks before Bayley-III testing |
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| Bayley-III, then BSID-II | Active Comparator | Receive Bayley-III testing 4-8 weeks before BSID-II testing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bayley Scales of Infant Development-II | Diagnostic Test | Individually administered test, designed to evaluate the developmental functioning of infants and small children, between 1 and 42 months of age. The purpose of the test is to identify infants and children with developmental delay. BSID-II was published in 1993. BSID-II provides normative data from two scales - Mental Development Index (MDI), and Psychomotor Development Index (PDI). |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score. | 18-22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score. | 18-22 months | |
| Proportion of infants classified as having "developmental delay" (MDI <70 on BSID-II or either Language or Cognitive Score <70 on the Bayley-III). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara B. DeMauro, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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| Bayley Scales of Infant Development-III | Diagnostic Test | Individually administered test, designed to evaluate the developmental functioning of infants and small children, between 1 and 42 months of age. The purpose of the test is to identify infants and children with developmental delay. BSID-III was released in 2006. BSID-III provides normative data from five scales - Cognitive, Language, Motor, Social-Emotional, and Adaptive. |
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| 18-22 months |
| The mean difference in scores between time point one and time point two (a measure of learning or training). | 18-22 months |