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

NCT02887664 | Unknown

• 1 other identifier: 0285-16-TLV-DM
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Small for Gestational Age Infants; Appropriate for Gestational Age Infants

Outcome Measures

Primary Outcomes (1)

• Cord blood analysis

  Determination of the cord blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of the n-6:n-3 ratio

  at time of delivery

Secondary Outcomes (1)

• Maternal blood analysis

  at time of delivery

Study Arms (2)

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 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

Interventions

Blood test PROCEDURE

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; Blood test in Mothers of SGA Infants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mothers of term or or near term infants after delivery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Sourasky medical center (Ichilov)

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dror Mandel, MD

  Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Mandel, MD

CONTACT

+97236925690; drorm@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 2, 2016
• Study Start: October 2, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)