Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
Verified December 2013 by Children's Hospital of Philadelphia
University of Pennsylvania
Information provided by (Responsible Party):
Sara DeMauro, Children's Hospital of Philadelphia
First received: June 13, 2011
Last updated: December 31, 2013
Last verified: December 2013
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.
||Time Perspective: Prospective
||A Randomized Crossover Study to Evaluate Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||18 Months to 22 Months
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Birth weight <2000 grams and <32 weeks
- Corrected age of 18-22 months.
- 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.
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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
|The Children's Hospital of Philadelphia
|Philadelphia, Pennsylvania, United States, 19104 |
|Principal Investigator: Sara B. DeMauro, MD |
Children's Hospital of Philadelphia
University of Pennsylvania
||Sara B. DeMauro, MD
||Children's Hospital of Philadelphia
No publications provided
ClinicalTrials.gov processed this record on July 20, 2014
||Sara DeMauro, Assistant Professor of Pediatrics, Attending Neonatologist, Children's Hospital of Philadelphia
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 13, 2011
||December 31, 2013
||United States: Institutional Review Board