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

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.

Study Overview

• Status: Completed
• Conditions: Infant Development
• Intervention / Treatment: Diagnostic test: Bayley Scales of Infant Development-II; Diagnostic test: Bayley Scales of Infant Development-III

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BSID-II, then Bayley-III; Receive BSID-II testing 4-8 weeks before Bayley-III testing	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).; Other Names: BSID-II; Diagnostic test: 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.; Other Names: Bayley-III; BSID-III
Active Comparator: Bayley-III, then BSID-II; Receive Bayley-III testing 4-8 weeks before BSID-II testing	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).; Other Names: BSID-II; Diagnostic test: 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.; Other Names: Bayley-III; BSID-III

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: Sara B. DeMauro, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 10-007937

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No