An observational study in Autism Spectrum Disorder and Complication of Prematurity, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 1 Hour to 1 Day, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Hadassah Medical Organization · Observational
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:
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:
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 400 is above the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
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neonatal intensive care units newborn ward
Exclusion Criteria:
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
Time frame: 30 months
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
Time frame: 30 months
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization