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

Not Applicable

Completed

• Conditions: Infant Development
• Interventions: Diagnostic Test: Bayley Scales of Infant Development-II; Diagnostic Test: Bayley Scales of Infant Development-III

• Registration Number: NCT01373177
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BSID-II, then Bayley-III	Bayley Scales of Infant Development-II	Receive BSID-II testing 4-8 weeks before Bayley-III testing
Bayley-III, then BSID-II	Bayley Scales of Infant Development-II	Receive Bayley-III testing 4-8 weeks before BSID-II testing
Bayley-III, then BSID-II	Bayley Scales of Infant Development-III	Receive Bayley-III testing 4-8 weeks before BSID-II testing
BSID-II, then Bayley-III	Bayley Scales of Infant Development-III	Receive BSID-II testing 4-8 weeks before Bayley-III testing

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The mean difference in scores between time point one and time point two (a measure of learning or training).	18-22 months
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

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States