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

Children's Hospital of Philadelphia119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

119

Conditions

Infant Development

Interventions

Bayley Scales of Infant Development-IIDIAGNOSTIC_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).

Bayley Scales of Infant Development-IIIDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 22 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.

Time frame: 18-22 months

Secondary Outcomes

Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score.

Time frame: 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).

Time frame: 18-22 months

The mean difference in scores between time point one and time point two (a measure of learning or training).

Time frame: 18-22 months

Data from ClinicalTrials.gov

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