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The Correlation Between the n-6:n-3 Ratio and Inflammatory Markers in Small for Gestational Age (SGA) Infants Compared With Appropriate for Gestational Age (AGA) Infants

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ClinicalTrials.gov Identifier: NCT02887664
Recruitment Status : Not yet recruiting
First Posted : September 2, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:

Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy and lactation for the prevention of preterm birth, beneficial effects on fetal development, visual and cognitive development and other functional outcomes of the infants.

The aim of the present study is to assess the correlation between ratio of n-3:n-6 fatty acid and inflammation markers in SGA infants compared with appropriate for gestational age (AGA) infants. The investigators hypothesize that in SGA infants n-3 and n-6 fatty acid concentrations in cord blood will differ from those observed in AGA and might correlate with the level of circulating mediators.


Condition or disease Intervention/treatment
Small for Gestational Age Infants Appropriate for Gestational Age Infants Procedure: Blood test

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Correlation Between the n-6:n-3 Ratio and Inflammatory Markers in Small for Gestational Age (SGA) Infants Compared With Appropriate for Gestational Age (AGA) Infants
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : January 2019

Group/Cohort Intervention/treatment
Blood test in Mothers of SGA Infants
In mothers of Small for Gestational Age (SGA) Infants, maternal and cord blood test will be performed
Procedure: Blood test
Blood will be drawn from mother's vein and from the cord to test for n-6:n-3 ratio and inflammatory markers: CRP, IL-6, TPO and TNF-alpha markers

Blood test in Mothers of AGA infants
In mothers of Appropriate for Gestational Age (AGA) Infants, maternal and cord blood test will be performed
Procedure: Blood test
Blood will be drawn from mother's vein and from the cord to test for n-6:n-3 ratio and inflammatory markers: CRP, IL-6, TPO and TNF-alpha markers




Primary Outcome Measures :
  1. Cord blood analysis [ Time Frame: at time of delivery ]
    Determination of the cord blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of the n-6:n-3 ratio


Secondary Outcome Measures :
  1. Maternal blood analysis [ Time Frame: at time of delivery ]
    Determination of the maternal blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of n-6:n-3 ratio


Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mothers of term or or near term infants after delivery
Criteria

Inclusion Criteria:

  • Mothers of SGA infants ( above 35 week of gestation)
  • Mothers of term and near-term AGA infants

Exclusion Criteria:

  • Maternal chronic diseases, smoking, diabetes, alcohol use, pregnancy-associated hypertension and pre-eclampsia
  • Neonatal depression
  • Congenital malformations
  • Intrauterine infections
  • Chromosomal aberrations
  • Mothers interested in cord blood banking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887664


Contacts
Contact: Dror Mandel, MD +97236925690 drorm@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Dror Mandel, MD Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02887664     History of Changes
Other Study ID Numbers: 0285-16-TLV-DM
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No