Autism Spectrum DisorderASD-CXCR4NCT01686685
Correlation of CXCR4 Expression in Premature Infants With a Diagnosis of Autism at 24 Months
An observational study of Autism Spectrum Disorder and Complication of Prematurity, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Preterm children are at increased risk for autism spectrum disorders, with an estimated rate of 10%. In the US, about 1 in 8 pregnancies ends with a premature birth. Therefore, individuals with ASD who were born prematurely form a substantial body of children diagnosed with ASD. Read more about this study
- Who is it for?
- Ages 1 hour to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Complication of Prematurity
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to 1 Apr 2018
- 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 1 hour to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Study population: neonatal intensive care units newborn ward
Who may be able to join
- Parents gave informed consent approved by the Institutional Review Board
- Gestational week 28-34 as determined by an ultrasound during the first trimester
- Singleton or twin pregnancy
Who cannot join
- Major anatomical abnormalities as detected on prenatal US
- Genetic syndrome as detected by prenatal US, MRI or chorioamniocentesis
- Obvious anatomical abnormalities or dysmorphic features detected on physical examination immediately following birth
- Triplet pregnancy
- Mother known or suspected to consume alcohol or illegal drugs during pregnancy
- Mother took medications during pregnancy that are known to have adverse affects on development (e.g. anti-epileptics)
- Family history of genetic syndrome related to developmental delays, that was not ruled out during current pregnancy (e.g. sibling with Tuberous Sclerosis or fragile X)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Correlation Between Expression of Proteins That Are Essential for Embryonic Brain Development and Neurodevelopmental Outcomes at 2 Years of Age in Premature Infants.
Preterm children are at increased risk for autism spectrum disorders, with an estimated rate of 10%. In the US, about 1 in 8 pregnancies ends with a premature birth. Therefore, individuals with ASD who were born prematurely form a substantial body of children diagnosed with ASD.
Premature birth confers an insult to the newborn at a neurologically vulnerable stage. Prematurity associated changes in oxygen tension can be detrimental to developing organs, the brain being one of the most rapidly developing organs in the second half of the pregnancy. Changes in oxygen tension mediate activation of proteins that change the course of cell development.
Read more
In this study, we plan to measure changes in the expression of 3 proteins that may be affected by changes in oxygen level at birth. We will study the interaction between the proteins' levels in the first few days after premature birth with a diagnosis of ASD at 2 years of age. The proteins are:
- VEGF (Vascular Endothelial Growth Factor), a protein that takes part in creating new blood vessels during embryonic development.
- Hypoxia-inducible factor -1(HIF-1), a key protein that coordinates expression of different genes, many with developmentally critical functions.
- CXCR4, a cell surface protein that is activated by SDF-1. SDF- 1 is a molecule that regulates migration of cells to their target destination during embryonic life. CXCR4 is expressed in areas of the brain and on cells that are known to be associated with ASD.
We hypothesis that changes in oxygen tension in premature babies initiates a cascade of events that lead to changes in cell mobility via abnormal CXCR4 expression. This change leads to abnormal neurodevelopment.
The investigators' primary aim is to find if there is a correlation between postnatal levels of expression of HIF-1, CXCR4 and VEGF and a diagnosis of autism at age 24 months. The investigators' secondary aim is to find if there is a correlation between postnatal levels of expression of HIF-1, CXCR4 and VEGF and a language or neurocognitive delay.
Methods:
- Premature babies will be recruited in the first day post delivery.
- Blood samples will be collected at 3 time points during their hospitalization, and the expression of HIF-1, CXCR4 and VEGF will be determined.
- Infants will undergo a complete developmental evaluation at 18-24 months of age .
- Postnatal levels of HIF, CXCR4 and VEGF will be plotted against the results of the developmental evaluation.
- Keywords
- ASD, autism, prematurity, oxygen-dependant gene activation, CXCR4, Language delay, Cognitive delay
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Premature Birth, Language Development Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of ASD at 24 months corrected age
Participants will be screened at 18 and 24 months for autism using the MCHAT questionnaire all positive screens will be referred for a complete developmental evaluation by child psychologist and developmental pediatrician: History, assessment (ADOS) and clinical judgement based on DSM criteria
Measured: 30 months
Secondary outcomes (1)
Language or cognitive delay at 24 months corrected age
Participants will be screened by questionnaires at 18 and 24 months. all positive screens will be referred for a full developmental evaluation using the Mullen Scales of Early learning
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2013
- Primary completionApr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Begin, MD, Study director, Hadassah HMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686685
- Sponsor's protocol ID
- begin1HMO-CTIL
- Acronym
- ASD-CXCR4
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2012
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Correlation Between Expression of Proteins That Are Essential for Embryonic Brain Development and Neurodevelopmental Outcomes at 2 Years of Age in Premature Infants.
- ClinicalTrials.gov ID
- NCT01686685
- Acronym / sponsor ID
- ASD-CXCR4 / begin1HMO-CTIL
- Keywords
- ASD, autism, prematurity, oxygen-dependant gene activation, CXCR4, Language delay, Cognitive delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 18 Sep 2012 (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.
Preterm children are at increased risk for autism spectrum disorders, with an estimated rate of 10%. In the US, about 1 in 8 pregnancies ends with a premature birth. Therefore, individuals with ASD who were born prematurely form a substantial body of children diagnosed with ASD.
Premature birth confers an insult to the newborn at a neurologically vulnerable stage. Prematurity associated changes in oxygen tension can be detrimental to developing organs, the brain being one of the most rapidly developing organs in the second half of the pregnancy. Changes in oxygen tension mediate activation of proteins that change the course of cell development.
In this study, we plan to measure changes in the expression of 3 proteins that may be affected by changes in oxygen level at birth. We will study the interaction between the proteins' levels in the first few days after premature birth with a diagnosis of ASD at 2 years of age. The proteins are:
- VEGF (Vascular Endothelial Growth Factor), a protein that takes part in creating new blood vessels during embryonic development.
- Hypoxia-inducible factor -1(HIF-1), a key protein that coordinates expression of different genes, many with developmentally critical functions.
- CXCR4, a cell surface protein that is activated by SDF-1. SDF- 1 is a molecule that regulates migration of cells to their target destination during embryonic life. CXCR4 is expressed in areas of the brain and on cells that are known to be associated with ASD.
We hypothesis that changes in oxygen tension in premature babies initiates a cascade of events that lead to changes in cell mobility via abnormal CXCR4 expression. This change leads to abnormal neurodevelopment.
The investigators' primary aim is to find if there is a correlation between postnatal levels of expression of HIF-1, CXCR4 and VEGF and a diagnosis of autism at age 24 months. The investigators' secondary aim is to find if there is a correlation between postnatal levels of expression of HIF-1, CXCR4 and VEGF and a language or neurocognitive delay.
Methods:
- Premature babies will be recruited in the first day post delivery.
- Blood samples will be collected at 3 time points during their hospitalization, and the expression of HIF-1, CXCR4 and VEGF will be determined.
- Infants will undergo a complete developmental evaluation at 18-24 months of age .
- Postnatal levels of HIF, CXCR4 and VEGF will be plotted against the results of the developmental evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- neonatal intensive care units newborn ward
Key inclusion criteria (3 listed)
- Parents gave informed consent approved by the Institutional Review Board
- Gestational week 28-34 as determined by an ultrasound during the first trimester
- Singleton or twin pregnancy
Key exclusion criteria (7 listed)
- Major anatomical abnormalities as detected on prenatal US
- Genetic syndrome as detected by prenatal US, MRI or chorioamniocentesis
- Obvious anatomical abnormalities or dysmorphic features detected on physical examination immediately following birth
- Triplet pregnancy
- Mother known or suspected to consume alcohol or illegal drugs during pregnancy
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
Diagnosis of ASD at 24 months corrected age
Time frame: 30 months
Participants will be screened at 18 and 24 months for autism using the MCHAT questionnaire all positive screens will be referred for a complete developmental evaluation by child psychologist and developmental pediatrician: History, assessment (ADOS) and clinical judgement based on DSM criteria
1 secondary outcome
Language or cognitive delay at 24 months corrected age
Time frame: 30 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 12 Apr 2018.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Michal Begin, MD study director
Hadassah HMO
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 Autism Spectrum Disorder and Complication of Prematurity, run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 7 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 12 Apr 2018. 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 Israel. 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?
Diagnosis of ASD at 24 months corrected age (time frame: 30 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 12 Apr 2018.