Omega-6/Omega-3 Ratio and Neural Development in Preterm Infants.

NCT02339727 | Completed Phase 1

• 1 other identifier: Ayham alshweki
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are important in neurodevelopment of term and preterm infants. This study tried to determine the utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature infants less than 1500 grams and / or less than 32 weeks of gestational age. To evaluate values of fatty acids they have in blood and psychomotor development they achieve.

Conditions

Impaired Psychomotor Development

Keywords

Omega-3; Omega-6

Outcome Measures

Primary Outcomes (1)

• Levels of fatty acids in blood

  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 Outcomes (1)

• Psychomotor development

  from september 2012 to november 2013 (at two years of corrected age)

Study Arms (2)

Omega-6/omega-3=2/1 milk formula

ACTIVE COMPARATOR

Preterm infants will receive a formulas supplemented with Docosahexaenoic acid and Arachidonic acid with a relationship omega 6/omega 3 = 2/1.

Dietary Supplement: Preterm infants formula

Omega-6/omega-3=1/1 milk formula

ACTIVE COMPARATOR

preterm infants will receive other formulas with Docosahexaenoic acid and Arachidonic acid, but with a ratio of 1/1.

Dietary Supplement: Preterm infants formula

Interventions

Preterm infants formula DIETARY_SUPPLEMENT

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.

Omega-6/omega-3=1/1 milk formula; Omega-6/omega-3=2/1 milk formula

Eligibility Criteria

• Age: 1 Minute - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ayham alshweki: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: //www.idisantiago.es/

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: January 15, 2015
• Study Start: July 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: September 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01