DevelopmentNCT02309697
Neurodevelopmental Outcomes of Preterm and Term Children
An observational study of Development, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study will utilize two validated tools for assessing child development and behavior, to investigate the outcomes for children born preterm compared with those born at full term. Two hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be enrolled. Read more about this study
- Who is it for?
- Ages 6 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Development
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2015
- Phase
- Observational
- 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 6 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 200 children born on or after January 1, 2011 at Mount Sinai or admitted to the Mount Sinai Hospital for newborn care.
Who may be able to join
- Born on or after January 1, 2011
- Admitted to the Mount Sinai Hospital for newborn care
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
This study will utilize two validated tools for assessing child development and behavior, to investigate the outcomes for children born preterm compared with those born at full term. Two hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be enrolled. Parents will be asked to complete a behavioral assessment questionnaire, and which will assess development in an examination administered by a trained occupational therapist at Mount Sinai Hospital.
Read the detailed description
This research will be completed at Mount Sinai Hospital. All participants will be identified from Mount Sinai Hospital records of infants born at MSH and/or cared for in the Mount Sinai NICU on or after January 1, 2011, at full term or preterm. The study team will contact the parents of eligible potential participants by telephone to explain the study and ask if the parent will consent to their child's participation. If the parent agrees, we will make an appointment for the child to come to Mount Sinai for the evaluation using the Bayley-III. The parents will be mailed the study consent form, a fact sheet with information about the study, and the CBCL to complete before they bring their child to their appointment. Mount Sinai records from the birth hospitalization will be reviewed for the birth history and medical comorbidities. Mount Sinai medical records of the mother's obstetric care will also be accessed to obtain medical history from the pregnancy. If a participating child has received outpatient care at Mount Sinai, the investigators will access their record in Epic to obtain scores from previous developmental assessments and records of medical comorbidities. If they have not attended the Mount Sinai clinic, but have received outpatient care elsewhere, the parents will be asked to provide contact information for their pediatrician, and for permission to obtain their child's records.
- Conditions
- Development
- Keywords
- Development, Assessments, Premature birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Full Term | Children born at full term on or after Jan 1, 2011 | |
| PreTerm | Children born preterm on or after Jan 1, 2011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behavior Checklist (CBCL)
The CBCL, completed by a primary caregiver, is a standardized assessment of behavioral problems categorized into externalizing or internalizing behaviors.
Measured: day 1
Secondary outcomes (1)
Bayley Scales of Development III (BayleyIII)
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) is used to measure developmental and behavioral outcomes. The Bayley-III is a standardized assessment of cognitive, motor, and language development administered by a trained researcher. The Bayley-III also includes social and emotional development questionnaire that is completed by a primary caregiver.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Study goals rolled into a broader study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DevelopmentStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemarie Stroustrup, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309697
- Sponsor's protocol ID
- GCO 12-0332-0001
- Status last verified
- Jan 2016
- First submitted
- 3 Dec 2014
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcomes of Preterm and Term Children
- ClinicalTrials.gov ID
- NCT02309697
- Acronym / sponsor ID
- GCO 12-0332-0001
- Conditions
- Development
- Keywords
- Development, Assessments, Premature birth
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study goals rolled into a broader study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Dec 2014 (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.
This study will utilize two validated tools for assessing child development and behavior, to investigate the outcomes for children born preterm compared with those born at full term. Two hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be enrolled. Parents will be asked to complete a behavioral assessment questionnaire, and which will assess development in an examination administered by a trained occupational therapist at Mount Sinai Hospital.
Detailed description
This research will be completed at Mount Sinai Hospital. All participants will be identified from Mount Sinai Hospital records of infants born at MSH and/or cared for in the Mount Sinai NICU on or after January 1, 2011, at full term or preterm. The study team will contact the parents of eligible potential participants by telephone to explain the study and ask if the parent will consent to their child's participation. If the parent agrees, we will make an appointment for the child to come to Mount Sinai for the evaluation using the Bayley-III. The parents will be mailed the study consent form, a fact sheet with information about the study, and the CBCL to complete before they bring their child to their appointment. Mount Sinai records from the birth hospitalization will be reviewed for the birth history and medical comorbidities. Mount Sinai medical records of the mother's obstetric care will also be accessed to obtain medical history from the pregnancy. If a participating child has received outpatient care at Mount Sinai, the investigators will access their record in Epic to obtain scores from previous developmental assessments and records of medical comorbidities. If they have not attended the Mount Sinai clinic, but have received outpatient care elsewhere, the parents will be asked to provide contact information for their pediatrician, and for permission to obtain their child's records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Term | – | –Children born at full term on or after Jan 1, 2011 |
| PreTerm | – | –Children born preterm on or after Jan 1, 2011 |
Who may qualify
- Ages
- 6 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 200 children born on or after January 1, 2011 at Mount Sinai or admitted to the Mount Sinai Hospital for newborn care.
Key inclusion criteria (2 listed)
- Born on or after January 1, 2011
- Admitted to the Mount Sinai Hospital for newborn care
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child Behavior Checklist (CBCL)
Time frame: day 1
The CBCL, completed by a primary caregiver, is a standardized assessment of behavioral problems categorized into externalizing or internalizing behaviors.
1 secondary outcome
Bayley Scales of Development III (BayleyIII)
Time frame: day 1
Results and safety
The study was stopped early (reason given: Study goals rolled into a broader study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
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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.
Annemarie Stroustrup, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development, run by Icahn School of Medicine at Mount Sinai 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 1 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: stopped early, as of the sponsor's last update on 14 Jan 2016. 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 was stopped early (reason given: Study goals rolled into a broader study). Results are not available in the source record.
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?
Child Behavior Checklist (CBCL) (time frame: day 1). 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 14 Jan 2016.