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Effect of Mother DHA Supplementation on Premature Newborn.

Primary Purpose

Oxidative Stress

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
DHA
control
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oxidative Stress focused on measuring neonates, DHA

Eligibility Criteria

1 Hour - 6 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hospital San Cecilio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DHA supplementation

Control

Arm Description

mothers consuming 900 mg DHA/day and their neonates.

follow on capsules without probiotics

Outcomes

Primary Outcome Measures

blood and milk samples
Assessment of oxidative stress

Secondary Outcome Measures

Blood
inflammation and bone development parameters

Full Information

First Posted
September 3, 2013
Last Updated
November 30, 2015
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT01940640
Brief Title
Effect of Mother DHA Supplementation on Premature Newborn.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress
Keywords
neonates, DHA

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHA supplementation
Arm Type
Experimental
Arm Description
mothers consuming 900 mg DHA/day and their neonates.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
follow on capsules without probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA
Other Intervention Name(s)
Docosahexaenoic acid
Intervention Description
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
Intervention Name(s)
control
Other Intervention Name(s)
Follow on capsules without probiotics
Intervention Description
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).
Primary Outcome Measure Information:
Title
blood and milk samples
Description
Assessment of oxidative stress
Time Frame
at delivery
Secondary Outcome Measure Information:
Title
Blood
Description
inflammation and bone development parameters
Time Frame
at delivery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio J Ochoa, Ph.D.
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Cecilio
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

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