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NCT Number: NCT01373177

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

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.

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Key information

Conditions

Infant Development

Age range

18 month–22 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bayley Scales of Infant Development-II

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).

Other names: BSID-II

Bayley Scales of Infant Development-III

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.

Other names: Bayley-III, BSID-III

Primary outcomes

  1. The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.

    Time frame: 18-22 months

Secondary outcomes

  1. Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score.

    Time frame: 18-22 months

  2. 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

  3. The mean difference in scores between time point one and time point two (a measure of learning or training).

    Time frame: 18-22 months

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 14, 2011
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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