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

This study is currently recruiting participants.
Verified April 2013 by Children's Hospital of Philadelphia
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Sara DeMauro, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01373177
First received: June 13, 2011
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Infant Development

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Randomized Crossover Study to Evaluate Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score. [ Time Frame: 18-22 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score. [ Time Frame: 18-22 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The mean difference in scores between time point one and time point two (a measure of learning or training). [ Time Frame: 18-22 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
BSID II - Bayley III
Receive BSID-II testing 4-8 weeks before Bayley-III testing
Bayley III - BSID II
Receive Bayley-III testing 4-8 weeks before BSID-II testing

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.

  Eligibility

Ages Eligible for Study:   18 Months to 22 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infants 18-22 months of age who weighed <2000 grams at birth and who were <32 weeks gestational age. Enrollment will reflect the ethnic and racial background of the maternal and neonatal populations at this institution.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373177

Contacts
Contact: Meghan Sharp 215-590-3614 sharpm@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Sara B. DeMauro, MD            
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Investigators
Principal Investigator: Sara B. DeMauro, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Sara DeMauro, Assistant Professor of Pediatrics, Attending Neonatologist, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01373177     History of Changes
Other Study ID Numbers: 10-007937
Study First Received: June 13, 2011
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013