Omega-6/Omega-3 Ratio and Neural Development in Preterm Infants. (NCT02339727) | Clinical Trial Compass
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 range
1 Minute – 2 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Levels of fatty acids in blood
Timeframe: from July 2010 to august 2012 (from the birth to 1 years old)