Effect of Mother DHA Supplementation on Premature Newborn.

NCT ID: NCT01940640

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-11-30

Brief Summary

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.

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.

Conditions

Oxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

DHA supplementation

mothers consuming 900 mg DHA/day and their neonates.

Group Type: EXPERIMENTAL

DHA

Intervention Type: DIETARY_SUPPLEMENT

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).

Control

follow on capsules without probiotics

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Docosahexaenoic acid; Follow on capsules without probiotics

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Julio J. Ochoa

Julio J. Ochoa

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julio J Ochoa, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Hospital San Cecilio

Granada, Granada, Spain

Countries

Spain

Other Identifiers

AGL2011-24014

Identifier Type: -

Identifier Source: org_study_id