Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years

Study Overview
=================
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.

Official Title
-----------------
A Randomized Crossover Study to Evaluate Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years

Conditions
-----------------
Infant Development

Intervention / Treatment
-----------------
* Diagnostic Test: Bayley Scales of Infant Development-II
* Diagnostic Test: Bayley Scales of Infant Development-III


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 22 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BSID-II, then Bayley-III<br>Receive BSID-II testing 4-8 weeks before Bayley-III testing | Diagnostic Test: Bayley Scales of Infant Development-II<br>* 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).<br>* Other names: BSID-II;Diagnostic Test: Bayley Scales of Infant Development-III<br>* 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.<br>* Other names: BSID-III;|
| Active Comparator: Bayley-III, then BSID-II<br>Receive Bayley-III testing 4-8 weeks before BSID-II testing | Diagnostic Test: Bayley Scales of Infant Development-II<br>* 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).<br>* Other names: BSID-II;Diagnostic Test: Bayley Scales of Infant Development-III<br>* 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.<br>* Other names: BSID-III;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). |  | 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 |