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

Appropriate for Gestational Age Infants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02887664
• Other study ID #: 0285-16-TLV-DM
• Status: Recruiting
• Start date: October 2, 2018
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Dror Mandel, MD
• Phone: +97236925690
• Email: drorm[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Appropriate for Gestational Age Infants
• Small for Gestational Age Infants

Intervention

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

Locations

Country	Name	City	State
Israel	Sourasky medical center (Ichilov)	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal blood analysis	Determination of the maternal blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of n-6:n-3 ratio	at time of delivery