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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373177
• Other study ID #: 10-007937
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: February 2015

Study information

• Verified date: November 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 22 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development

Intervention

Diagnostic Test:
• Bayley 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).
• Bayley 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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.		18-22 months
Secondary	Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score.		18-22 months
Secondary	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
Secondary	The mean difference in scores between time point one and time point two (a measure of learning or training).		18-22 months