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

NCT ID: NCT01373177

Last Updated: 2019-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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

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Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BSID-II, then Bayley-III

Receive BSID-II testing 4-8 weeks before Bayley-III testing

Group Type ACTIVE_COMPARATOR

Bayley Scales of Infant Development-II

Intervention Type DIAGNOSTIC_TEST

Individually 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).

Bayley Scales of Infant Development-III

Intervention Type DIAGNOSTIC_TEST

Individually 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.

Bayley-III, then BSID-II

Receive Bayley-III testing 4-8 weeks before BSID-II testing

Group Type ACTIVE_COMPARATOR

Bayley Scales of Infant Development-II

Intervention Type DIAGNOSTIC_TEST

Individually 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).

Bayley Scales of Infant Development-III

Intervention Type DIAGNOSTIC_TEST

Individually 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.

Interventions

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Bayley Scales of Infant Development-II

Individually 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).

Intervention Type DIAGNOSTIC_TEST

Bayley Scales of Infant Development-III

Individually 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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BSID-II Bayley-III BSID-III

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

22 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara B. DeMauro, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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10-007937

Identifier Type: -

Identifier Source: org_study_id

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