CompletedPhase 1/2

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

40 participantsStarted 2010-07

Plain-language 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.

Who can participate

Age range1 Minute – 2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Levels of fatty acids in blood

Timeframe: from July 2010 to august 2012 (from the birth to 1 years old)

Trial details

NCT IDNCT02339727

SponsorAyham alshweki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Impaired Psychomotor Development trials