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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02887664
Enrollment
60
Registered
2016-09-02
Start date
2018-10-02
Completion date
2020-12-31
Last updated
2019-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appropriate for Gestational Age Infants, Small for Gestational Age Infants

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.

Interventions

PROCEDUREBlood 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

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cord blood analysisat time of deliveryDetermination of the cord blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of the n-6:n-3 ratio

Secondary

MeasureTime frameDescription
Maternal blood analysisat time of deliveryDetermination of the maternal blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of n-6:n-3 ratio

Countries

Israel

Contacts

Primary ContactDror Mandel, MD
drorm@tlvmc.gov.il+97236925690

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026