Effect of Mother DHA Supplementation on Premature Newborn.

Multidisciplinary Study of the Effect of the Mother suplementación During the Lactation With High Doses of DHA on Diverse Aspects Related to the Development of the Premature Newborn in the First Year of Life.

To date, the investigations in the field of the supplementation with DHA in premature babies have been focused on the study of neuronal and visual development, giving place to contradictory and ambiguous results, because they did not consider in many cases important aspects of this supplementation, such as the mother´s diet, dose, duration, etc., and precise studies have not been performed in the field of the oxidative damage, inflammation and bone development in this population.

Hypothesis: If the composition of the mother´s milk is modified on the basis of her diet, a mother supplementation with high doses of DHA will increase proportionally the levels of this fatty acid in her milk, fact that will allows the premature newborn child receive a major dose of this fatty acid, and therefore this way, we will manage to improve the neuronal and visual development and to take part on the inflammatory process, oxidative damage and its evolution, together with the development or bone mass increase in the premature baby.

Aims: Overall we aim to evaluate in a multidisciplinary way the effect of a mother supplementation during the lactation with high doses of DHA on the development and wellness of the premature newborn children. We try to deepen into the effect on the neuronal and visual development and to study, for the first time, the effect on the oxidative damage, pro- and antiinflammatory citoquines activity and bone metabolism in this group of newborn babies.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress
• Intervention / Treatment: Dietary supplement: DHA; Dietary supplement: control

Detailed Description

Experimental design: We will establish two groups of premature newborn children (<34 weeks) (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA (900 mg/day) during the lactation (minimum period of 3 months). In addition, all the groups will be underwent to a nutritional surveillance (a follow-up of 48 hours and a questionnaire of frequency of consumption) and will be given nutritionally-balanced diets, insisting especially in the suitable consumption of fish (4 portions/week). Blood samples will be obtained in all the groups at the birth moment, at the week 40 of gestational age corrected in the groups of premature babies and at the end of the lactation in all the groups (minimum 3 months).We will obtain samples of mother´s milk (colostrum, transition and mature milk). In these samples we will study bone turnover biomarkers, pro - and anti-inflammatory citoquines and markers of aggression oxidative damage. In addition, we will perform psychomotor and visual development tests in the newborn children.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Hospital San Cecilio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm neonate, gestational age 30-34, PAEG (>P10, <P95), no pathologies.

Exclusion Criteria:

• Lactose intolerance, systemic illness, multiple gestation, cromosomopathies, antibacterial therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DHA supplementation; mothers consuming 900 mg DHA/day and their neonates.	Dietary supplement: DHA; We will establish two groups of premature newborn children (<34 weeks) (n=40) and one group of newborn children to term (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA (900 mg/day) during the lactation (minimum period of 3 months).; Other Names: Docosahexaenoic acid
Active Comparator: Control; follow on capsules without probiotics	Dietary supplement: control; We will establish two groups of premature newborn children (<34 weeks) (n=40) and one group of newborn children to term (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA during the lactation (minimum period of 3 months).; Other Names: Follow on capsules without probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood and milk samples	Assessment of oxidative stress	at delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood	inflammation and bone development parameters	at delivery

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Julio J Ochoa, Ph.D., Universidad de Granada

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 8, 2013
• First Posted (Estimate): September 12, 2013

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: neonates, DHA
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: AGL2011-24014