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Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates

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ClinicalTrials.gov Identifier: NCT02518126
Recruitment Status : Unknown
Verified August 2015 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Tracking Information
First Submitted Date August 4, 2015
First Posted Date August 7, 2015
Last Update Posted Date August 7, 2015
Study Start Date August 2015
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 6, 2015)
LIF Protein Level in IUGR Neonates vs. AGA neonates [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates
Official Title Comparison of LIF (Leukemia Inhibitory Factor) Level Between Neonates Who Are IUGR (Intra Uterine Growth Restriction) and Those Who Are AGA (Average for Gestational Age)
Brief Summary To see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses
Detailed Description

During embryonic development, there are several cytokines such as: LIF (Leukemia inhibitory factor), ciliary neurotrophic factor (CNTF), epidermal growth factor family (EGF), neuregulin 1 (NRG1) and transforming growth factor β (TGFβ) that were found are associated with neurogenesis and differentiation of brain cells .

LIF is a cytokine that is essential for the development of the central nervous system, and has recently been shown in rats that maternal LIF stimulates placental ACTH that in turn promotes secretion of fetal LIF from nRBC , which in turn promotes brain development of the fetus Other studies on IUGR (Intra Uterine Growth Restriction) have shown that IUGR fetuses have more CP (Cerebral palsy) than those who were AGA (Average for Gestational Age) The hypothesis is that LIF is related to the proper development of the nervous system in the fetus and by testing cord blood of embryos IUGR and the placenta we will find changes in LIF and ACTH compared with AGA fetuses level.

Studies have also shown a relationship between CP and IUGR, but the mechanism for this relationship is unclear.

The purpose of our research is to see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses, in one of two ways:

  • Changes in the secretion of ACTH in placenta
  • Changes in levels of LIF in the umbilical cord blood
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Cord blood and a small peace of the placenta
Sampling Method Non-Probability Sample
Study Population Pregnant women with fetuses who are AGA and those with fetuses that are IUGR
Condition to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA
Intervention Other: blood sample and tissue sample
After birth and fetal umbilical cord disconnection, a blood sample will be taken from the umbilical cord (cord blood) of IUGR and of AGA fetuses (5cc) for cytokine ELISA testing. Also a small sample of the placenta will be examined in order to assess the level of ACTH protein in IUGR and AGA embryos
Study Groups/Cohorts
  • control
    Women with IUGR embryos so that their fetal weight estimate puts them in a percentile bellow 10th percentile
    Intervention: Other: blood sample and tissue sample
  • IUGR
    Women with AGA embryos so that their fetal weight estimate puts them in a percentile between 20th and 80th percentiles
    Intervention: Other: blood sample and tissue sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 6, 2015)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women that the Fetal weight estimate puts the fetus bellow the 10th percentile and those that the fetal weight estimate are between 20th and 80th percentiles

Exclusion Criteria:

  • Women who do not agree
  • known Genetic diseases of abnormalities in the fetus
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02518126
Other Study ID Numbers 0176-15-RMB CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rambam Health Care Campus
Study Sponsor Rambam Health Care Campus
Collaborators Not Provided
Investigators Not Provided
PRS Account Rambam Health Care Campus
Verification Date August 2015