Infant Development
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTBayley Scales of Infant Development-II
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).
DIAGNOSTIC_TESTBayley Scales of Infant Development-III
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.
Sponsors
University of Pennsylvania
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 22 Months
Healthy volunteers
Yes
Inclusion criteria
* Birth weight \<2000 grams and \<32 weeks * Corrected age of 18-22 months.
Exclusion criteria
* English is not the primary language in the child's home. * Parent is unable to give informed consent for research participation. * Parent is unable to commit to returning for follow-up testing in 4-8 weeks. * Infant has severe medical illness or disability expected to impact his/her ability to participate in testing (ex: blindness, deafness, severe cerebral palsy, autism, tracheostomy). * No exclusion for economic status, gender, race or ethnicity. * Participation in a RCT that restricts timing and administration of developmental testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score. | 18-22 months |
Secondary
| Measure | 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). | 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 |
Countries
United States
Outcome results
None listed