Clinical Trials Directory

Trials / Completed

CompletedNCT01373177

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

A Randomized Crossover Study to Evaluate Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
119 (actual)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
All
Age
18 Months – 22 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBayley Scales of Infant Development-IIIndividually administered test, designed to evaluate the developmental functioning of infants and small children, between 1 and 42 months of age. The purpose of the test is to identify infants and children with developmental delay. BSID-II was published in 1993. BSID-II provides normative data from two scales - Mental Development Index (MDI), and Psychomotor Development Index (PDI).
DIAGNOSTIC_TESTBayley Scales of Infant Development-IIIIndividually administered test, designed to evaluate the developmental functioning of infants and small children, between 1 and 42 months of age. The purpose of the test is to identify infants and children with developmental delay. BSID-III was released in 2006. BSID-III provides normative data from five scales - Cognitive, Language, Motor, Social-Emotional, and Adaptive.

Timeline

Start date
2011-01-01
Primary completion
2015-02-01
Completion
2015-02-01
First posted
2011-06-14
Last updated
2019-11-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01373177. Inclusion in this directory is not an endorsement.