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
University of Pennsylvania
Information provided by (Responsible Party):
Sara DeMauro, Children's Hospital of Philadelphia
First received: June 13, 2011
Last updated: April 2, 2013
Last verified: April 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:
||September 2013 (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.
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 December 04, 2013
||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
||April 2, 2013
||United States: Institutional Review Board