Infant DevelopmentNCT01373177
Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
A study testing Bayley Scales of Infant Development-II and Bayley Scales of Infant Development-III in people with Infant Development, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 22 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Bayley Scales of Infant Development-II and Bayley Scales of Infant Development-III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth weight <2000 grams and <32 weeks
- Corrected age of 18-22 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Crossover Study to Evaluate 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.
Read the 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
- Infant Development
- Being tested
- Bayley Scales of Infant Development-II, Bayley Scales of Infant Development-III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bayley Scales of Infant Development-IIDiagnostic test
Also called BSID-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).
Bayley Scales of Infant Development-IIIDiagnostic test
Also called Bayley-III, BSID-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.
| Study group | Role | What they receive |
|---|---|---|
| BSID-II, then Bayley-III | Active comparator | Receive BSID-II testing 4-8 weeks before Bayley-III testing Receives: Diagnostic Test: Bayley Scales of Infant Development-II; Diagnostic Test: Bayley Scales of Infant Development-III |
| Bayley-III, then BSID-II | Active comparator | Receive Bayley-III testing 4-8 weeks before BSID-II testing Receives: Diagnostic Test: Bayley Scales of Infant Development-II; Diagnostic Test: Bayley Scales of Infant Development-III |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.
Measured: 18-22 months
Secondary outcomes (3)
Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score.
Measured: 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).
Measured: 18-22 months
The mean difference in scores between time point one and time point two (a measure of learning or training).
Measured: 18-22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Sara B. DeMauro, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373177
- Sponsor's protocol ID
- 10-007937
- Status last verified
- Nov 2019
- First submitted
- 13 Jun 2011
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study to Evaluate Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
- ClinicalTrials.gov ID
- NCT01373177
- Acronym / sponsor ID
- 10-007937
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Jan 2011 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BSID-II, then Bayley-III | Active comparator | Diagnostic Test: Bayley Scales of Infant Development-II, Diagnostic Test: Bayley Scales of Infant Development-IIIReceive BSID-II testing 4-8 weeks before Bayley-III testing |
| Bayley-III, then BSID-II | Active comparator | Diagnostic Test: Bayley Scales of Infant Development-II, Diagnostic Test: Bayley Scales of Infant Development-IIIReceive Bayley-III testing 4-8 weeks before BSID-II testing |
Who may qualify
- Ages
- 18 to 22 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth weight <2000 grams and <32 weeks
- Corrected age of 18-22 months.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bayley Scales of Infant Development-IIAlso: BSID-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 test | BSID-II, then Bayley-III, Bayley-III, then BSID-II |
| Bayley Scales of Infant Development-IIIAlso: Bayley-III, BSID-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. | Diagnostic test | BSID-II, then Bayley-III, Bayley-III, then BSID-II |
Primary outcome
The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.
Time frame: 18-22 months
3 secondary outcomes
Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score.
Time frame: 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).
Time frame: 18-22 months
The mean difference in scores between time point one and time point two (a measure of learning or training).
Time frame: 18-22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara B. DeMauro, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bayley Scales of Infant Development-II and Bayley Scales of Infant Development-III in people with Infant Development, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score. (time frame: 18-22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.