- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02339727
Omega-6/Omega-3 Ratio and Neural Development in Preterm Infants.
Clinical Trial of the Relation Between Omega-6/Omega-3 Ratio in Formula of Preterm Infants Less Than 1500 Grams and/or Less Than 32 Weeks Gestational Ages and Brunet Lezine Score at 2 Years of Live. Anuvis Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study took place in a single-center; it is a prospective randomized study of preterm infants less than 1500 grams and/or less than 32 weeks gestational age, admitted to the Neonatal Intensive Care Unit in the University Clinical Hospital of Santiago de Compostela. They were recruited for a period of 14 months (from July 2010 to august 2011) and followed from birth until 2 years of life.
40 children were included and followed in the study. Patients will be assigned randomly into two groups depending on the type of formula they are receiving. The group A of children will receive a formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2. And group B will receive other formula with DHA and ARA, but with a ratio of 1/1.
The classification of group A and B was made by simple random way; one birth in every group, continuously.
Implementation of breastfeeding will be promoted and will be fortified after 7 days of life, when the total amount of breast milk will be more than 1/2 of the total.
When breastfeeding will be insufficient or nonexistent, special formulas for premature babies will be given
During the follow-up of patients, will be measured:
- - Levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12 months.The determination will be carried out in collaboration with the Hospital de Cruces, Bilbao, Spain.
- - Evaluation of psychomotor development by Brunet-Lezine scale at 2 years of corrected age.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Living infants who were less than 1500 grams and/or less than 32 weeks gestational age, and whose parents accepted and subscribed the informed consent
Exclusion Criteria:
- Preterm infants with any malformation or deformation.
- Extreme preterm infants with gestational age less than 25 weeks.
- Infants whose parents couldn't follow up their children in our study center.
- Preterm infants who had a severe intra ventricular hemorrhage (more than grade 2).
- Premature infants who had severe periventricular leukomalacia (more than grade 2) because the latest two conditions can affect neurodevelopment.
- Finally, we excluded neonates who don't need supplementary milk nutrition, i.e. children with breastfeeding only.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Omega-6/omega-3=2/1 milk formula
Preterm infants will receive a formulas supplemented with Docosahexaenoic acid and Arachidonic acid with a relationship omega 6/omega 3 = 2/1.
|
The group 1 of children will receive a preterm infants formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2/1 during the first 3 months of life.
And group 2 will receive other Preterm infants formula very similar, but with a ratio of DHA and AA=1/1 also during the first 3 months of life.
|
Active Comparator: Omega-6/omega-3=1/1 milk formula
preterm infants will receive other formulas with Docosahexaenoic acid and Arachidonic acid, but with a ratio of 1/1.
|
The group 1 of children will receive a preterm infants formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2/1 during the first 3 months of life.
And group 2 will receive other Preterm infants formula very similar, but with a ratio of DHA and AA=1/1 also during the first 3 months of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of fatty acids in blood
Time Frame: from July 2010 to august 2012 (from the birth to 1 years old)
|
Levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12 months of live
|
from July 2010 to august 2012 (from the birth to 1 years old)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychomotor development
Time Frame: from september 2012 to november 2013 (at two years of corrected age)
|
Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.
|
from september 2012 to november 2013 (at two years of corrected age)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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