Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
A Randomized Crossover Study to Evaluate Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
1 other identifier
interventional
119
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 13, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedNovember 21, 2019
November 1, 2019
4.1 years
June 13, 2011
November 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.
18-22 months
Secondary Outcomes (3)
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
Study Arms (2)
BSID-II, then Bayley-III
ACTIVE COMPARATORReceive BSID-II testing 4-8 weeks before Bayley-III testing
Bayley-III, then BSID-II
ACTIVE COMPARATORReceive Bayley-III testing 4-8 weeks before BSID-II testing
Interventions
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).
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 Criteria
You may qualify if:
- Birth weight \<2000 grams and \<32 weeks
- Corrected age of 18-22 months.
You may not qualify if:
- 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).
- Participation in a RCT that restricts timing and administration of developmental testing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- University of Pennsylvaniacollaborator
Study Sites (1)
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sara B. DeMauro, MD
Children's Hospital of Philadelphia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2011
First Posted
June 14, 2011
Study Start
January 1, 2011
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 21, 2019
Record last verified: 2019-11