Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates

to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02518126
• Other study ID #: 0176-15-RMB CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: August 4, 2015
• Last updated: August 6, 2015
• Start date: August 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2015
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Growth Retardation
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LIF Protein Level in IUGR Neonates vs. AGA neonates		2 years	No