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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Levels of fatty acids in blood
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Psychomotor development
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
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