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

This study is ongoing, but not recruiting participants.
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: August 7, 2014
Last verified: August 2014
  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

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: November 2014
Estimated Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
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: August 7, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 22, 2014