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Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment
to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA Other: blood sample and tissue sample

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

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
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)
Study Start Date : August 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Group/Cohort Intervention/treatment
control
Women with IUGR embryos so that their fetal weight estimate puts them in a percentile bellow 10th percentile
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

IUGR
Women with AGA embryos so that their fetal weight estimate puts them in a percentile between 20th and 80th percentiles
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




Primary Outcome Measures :
  1. LIF Protein Level in IUGR Neonates vs. AGA neonates [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Cord blood and a small peace of the placenta


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with fetuses who are AGA and those with fetuses that are IUGR
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
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02518126    
Other Study ID Numbers: 0176-15-RMB CTIL
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Keywords provided by Rambam Health Care Campus:
LIF IUGR
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms