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

• Conditions: Small for Gestational Age Infants; Appropriate for Gestational Age Infants

• Registration Number: NCT02887664
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Study Start: 2018-10-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cord blood analysis	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

Name	Time	Method
Maternal blood analysis	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

Trial Locations

Locations (1)

Sourasky medical center (Ichilov); 🇮🇱 Tel-Aviv, Israel