to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGANCT02518126
Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates
An observational study of to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA, run by Rambam Health Care Campus.
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 Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA
- What is being tested?
- blood sample and tissue sample
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2017
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women with fetuses who are AGA and those with fetuses that are IUGR
Who may be able to join
- 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
Who cannot join
- Women who do not agree
- known Genetic diseases of abnormalities in the fetus
About this study
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)
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
Read the 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
- Being tested
- blood sample and tissue sample
- Keywords
- LIF IUGR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample and tissue sampleOther
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 group | Role | What they receive |
|---|---|---|
| control | Women with IUGR embryos so that their fetal weight estimate puts them in a percentile bellow 10th percentile Receives: 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 Receives: Other: blood sample and tissue sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
LIF Protein Level in IUGR Neonates vs. AGA neonates
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGAStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518126
- Sponsor's protocol ID
- 0176-15-RMB CTIL
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02518126
- Acronym / sponsor ID
- 0176-15-RMB CTIL
- Keywords
- LIF IUGR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Aug 2015 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: blood sample and tissue sampleWomen with IUGR embryos so that their fetal weight estimate puts them in a percentile bellow 10th percentile |
| IUGR | – | Other: blood sample and tissue sampleWomen with AGA embryos so that their fetal weight estimate puts them in a percentile between 20th and 80th percentiles |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women with fetuses who are AGA and those with fetuses that are IUGR
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Women who do not agree
- known Genetic diseases of abnormalities in the fetus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample and tissue sampleAfter 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 | Other | IUGR, control |
Primary outcome
LIF Protein Level in IUGR Neonates vs. AGA neonates
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA, run by Rambam Health Care Campus.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
LIF Protein Level in IUGR Neonates vs. AGA neonates (time frame: 2 years). 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 7 Aug 2015; AzTrials last refreshed its copy on 6 Nov 2026.