Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns

Not Applicable

Terminated

• Conditions: Premature
• Interventions: Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA

• Registration Number: NCT01062373
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Status Verified: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Childbirth between 34 and 35 GA
• Breast-feeding
• Caucasian
• Affiliation to social security
• Obtained consent from mother, and parents for the child
• Mother with balanced diet
• No allergy to eggs
• Single pregnancy

Exclusion Criteria

• Allergy to egg
• Unbalanced diet
• Diabetes
• Known digestive disease
• Counter-indication with breast-feeding
• Cigarettes (more than 5 per day)
• Alcoholism (daily consumption of alcohol)
• Multiple pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TG-DHA	Supplementation of lactating mothers who has delivered prematurely with DHA	TG-DHA: lactating mothers and their newborn with mothers supplemented with Triglyceride enriched in docosahexaenoic acid
GPL-DHA	Supplementation of lactating mothers who has delivered prematurely with DHA	GPL-DHA: lactating mothers and their newborn with mothers supplemented with Glycerophospholipid enriched in docosahexaenoic acid

Primary Outcome Measures

Name	Time	Method
To improve PUFA status in premature newborns	30 days

Secondary Outcome Measures

Name	Time	Method
PUFA in human milk (HM) and mothers	6 months
Impact on HM bioactives	6 months
Change in inflammation and oxydative stress	6 months
Genes expression in newborns	6 months
Link between mothers genetics and HM DHA level	6 months
Newborn survey at 6 month-old	6 months

Trial Locations

Locations (1)

Service de Médecine néonatale, Hôpital de la Conception; 🇫🇷 Marseille Cedex 05, France