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Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial.

ABSTRACT: Nutritional supplementation with polyunsaturated fatty acids is important in preterm infants neurodevelopment, but it is not known if the omega-6/omega-3 ratio affects this process. This study was designed to determine the effects of a balanced contribution of arachidonic acid in very preterm newborns fed with formula milk.This was a randomized trial, in which newborns <1500 g and/or <32 weeks gestational age were assigned to one of two groups, based on the milk formula they would receive during the first year of life. Initially, 60 newborns entered the study, but ultimately, group A was composed of 24 newborns, who were given formula milk with an ?-6/?-3 ratio of 2/1, and Group B was composed of 21 newborns, given formula milk with an ?-6/?-3 ratio of 1/1. The infants were followed up for two years: growth, visual-evoked potentials, brainstem auditory-evoked potentials, and plasma fatty acids were periodically measured, and psychomotor development was assessed using the Brunet Lézine scale at 24 months corrected age. A control group, for comparison of Brunet Lézine score, was made up of 25 newborns from the SEN1500 project, who were fed exclusively with breast milk.At 12 months, arachidonic acid values were significantly higher in group A than in group B (6.95 ± 1.55% vs. 4.55 ± 0.78%), as were polyunsaturated fatty acids (41.02 ± 2.09% vs. 38.08 ± 2.32%) achieved a higher average. Group A achieved a higher average Brunet Lézine score at 24 months than group B (99.9 ± 9 vs. 90.8 ± 11, p =0.028). The Brunet Lézine results from group A were compared with the control group results, with very similar scores registered between the two groups (99.9 ± 9 vs. 100.5 ± 7). There were no significant differences in growth or evoked potentials between the two formula groups.Very preterm infants who received formula with an ?-6/?-3 ratio of 2/1 had higher blood levels of essential fatty acids during the first year of life, and better psychomotor development, compared with very preterm newborns who consumed formula with an ?-6/?-3 of 1/1. Therefore, formula milk with an arachidonic acid quantity double that of docosahexaenoic acid should be considered for feeding very preterm infants.ClinicalTrials.gov Identifier NCT02503020.

SUBMITTER: Alshweki A

PROVIDER: S-EPMC4590272 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial.

Alshweki Ayham A Muñuzuri Alejandro Pérez AP Baña Ana M AM de Castro Ma José MJ Andrade Fernando F Aldamiz-Echevarría Luís L de Pipaón Miguel Sáenz MS Fraga José M JM Couce María L ML

Nutrition journal 20150930

<h4>Background & aims</h4>Nutritional supplementation with polyunsaturated fatty acids is important in preterm infants neurodevelopment, but it is not known if the omega-6/omega-3 ratio affects this process. This study was designed to determine the effects of a balanced contribution of arachidonic acid in very preterm newborns fed with formula milk.<h4>Methods</h4>This was a randomized trial, in which newborns <1500 g and/or <32 weeks gestational age were assigned to one of two groups, based on ...[more]

PMID: 26424477

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Project description:BackgroundInfections acquired in hospital are an important cause of morbidity and mortality in very preterm infants. Several small trials have suggested that supplementing the enteral diet of very preterm infants with lactoferrin, an antimicrobial protein processed from cow's milk, prevents infections and associated complications. The aim of this large randomised controlled trial was to collect data to enhance the validity and applicability of the evidence from previous trials to inform practice.MethodsIn this randomised placebo-controlled trial, we recruited very preterm infants born before 32 weeks' gestation in 37 UK hospitals and younger than 72 h at randomisation. Exclusion criteria were presence of a severe congenital anomaly, anticipated enteral fasting for longer than 14 days, or no realistic prospect of survival. Eligible infants were randomly assigned (1:1) to receive either enteral bovine lactoferrin (150 mg/kg per day; maximum 300 mg/day; lactoferrin group) or sucrose (same dose; control group) once daily until 34 weeks' postmenstrual age. Web-based randomisation minimised for recruitment site, gestation (completed weeks), sex, and single versus multifetal pregnancy. Parents, caregivers, and outcome assessors were unaware of group assignment. The primary outcome was microbiologically confirmed or clinically suspected late-onset infection (occurring >72 h after birth), which was assessed in all participants for whom primary outcome data was available by calculating the relative risk ratio with 95% CI between the two groups. The trial is registered with the International Standard Randomised Controlled Trial Number 88261002.FindingsWe recruited 2203 participants between May 7, 2014, and Sept 28, 2017, of whom 1099 were assigned to the lactoferrin group and 1104 to the control group. Four infants had consent withdrawn or unconfirmed, leaving 1098 infants in the lactoferrin group and 1101 in the sucrose group. Primary outcome data for 2182 infants (1093 [99·5%] of 1098 in the lactoferrin group and 1089 [99·0] of 1101 in the control group) were available for inclusion in the modified intention-to-treat analyses. 316 (29%) of 1093 infants in the intervention group acquired a late-onset infection versus 334 (31%) of 1089 in the control group. The risk ratio adjusted for minimisation factors was 0·95 (95% CI 0·86-1·04; p=0·233). During the trial there were 16 serious adverse events for infants in the lactoferrin group and 10 for infants in the control group. Two events in the lactoferrin group (one case of blood in stool and one death after intestinal perforation) were assessed as being possibly related to the trial intervention.InterpretationEnteral supplementation with bovine lactoferrin does not reduce the risk of late-onset infection in very preterm infants. These data do not support its routine use to prevent late-onset infection and associated morbidity or mortality in very preterm infants.FundingUK National Institute for Health Research Health Technology Assessment programme (10/57/49).

Project description:BackgroundNecrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants.MethodsThe study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age.ResultsA total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).ConclusionRepeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.

Project description:Study objectivesThis secondary analysis characterized sleep patterns for toddlers born preterm and tested effects of docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation on children's caregiver-reported sleep. Exploratory analyses tested whether child sex, birth weight, and caregiver depressive symptomatology were moderators of the treatment effect.MethodsOmega Tots was a single-site 180-day randomized (1:1), double-blinded, placebo-controlled trial. Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation, assigned to 180 days of daily 200 mg DHA + 200 mg AA supplementation or placebo (400 mg corn oil), and followed after the trial ended to age 26 to 32 months. Caregivers completed a sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire). Analyses compared changes in sleep between the DHA+AA and placebo groups, controlling for baseline scores. Exploratory post hoc subgroup analyses were conducted.ResultsEighty-one percent (ntx = 156; nplacebo = 150) of children had 180-day trial outcome data; 68% (ntx = 134; nplacebo = 122) had postintervention outcome data. Differences in change between the DHA+AA and placebo groups after 180 days of supplementation were not statistically significant for the entire cohort. Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P = .04; sleep problems odds ratio = 0.36, 95% confidence interval = 0.15, 0.82) and children of depressed caregivers (difference in nocturnal sleep change = 1.07, effect size = 0.65, P = .006; difference in total sleep change = 1.10, effect size = 0.50, P = .04) assigned to the treatment group showed improvements in sleep, compared to placebo.ConclusionsAlthough there is no evidence of an overall effect of DHA+AA supplementation on child sleep, exploratory post hoc analyses identified important subgroups of children born preterm who may benefit. Future research including larger samples is warranted.Clinical trial registrationRegistry: ClinicalTrials.gov; Identifier: NCT01576783.CitationBoone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic acid and arachidonic acid supplementation and sleep in toddlers born preterm: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2019;15(9):1197-1208.

Project description:Background:Epidemiologic studies link maternal seafood and n-3 (?-3) polyunsaturated fatty acid (PUFA) consumption with improved childhood cognitive development; trials show mixed results. Objective:We investigated effects of n-3 PUFA supplementation on child cognitive and visual outcomes. Methods:We systematically reviewed and meta-analyzed randomized controlled trials of n-3 PUFA supplementation in mothers or infants (age ?2 y) and evaluated standardized measures of cognitive or visual development up to age 18 y. Of 6286 abstracts and 669 full-text articles, 38 trials with 53 intervention arms were included. Data were extracted independently in duplicate. Findings were pooled using random-effects meta-analysis across supplementation periods (maternal, preterm, term infant); we also explored subgroup analyses stratified by supplementation period. Heterogeneity was explored using I2, stratified analysis, and meta-regression. Cognitive development was assessed by Bayley Scales of Infant Development mental and psychomotor developmental indexes (MDI, PDI) and intelligence quotient (IQ); visual acuity was assessed by electrophysiological or behavioral measures. Results:The 38 trials (mothers: n = 13; preterm infants: n = 7; term infants: n = 18) included 5541 participants. When we explored effects during different periods of supplementation, n-3 PUFA supplementation improved MDI in preterm infants (3.33; 95% CI: 0.72, 5.93), without statistically significant effects on PDI or IQ in different intervention period subgroups. Visual acuity [measured as the logarithm of the minimum angle of resolution (logMAR)] was improved by supplementation in preterm (-0.08 logMAR; 95% CI: -0.14, -0.01 logMAR) and term infants (-0.08 logMAR; 95% CI: -0.11, -0.05 logMAR), with a nonsignificant trend for maternal supplementation (-0.02 logMAR; 95% CI: -0.04, 0.00 logMAR). In main analyses pooling all supplementation periods, compared with placebo, n-3 PUFA supplementation improved MDI (n = 21 trials; 0.91; 95% CI: 0.005, 1.81; P = 0.049), PDI (n = 21 trials; 1.06 higher index; 95% CI: 0.10, 2.03; P = 0.031), and visual acuity (n = 24; -0.063 logMAR; 95% CI: -0.084, -0.041 logMAR; P < 0.001) but not IQ (n = 7; 0.20; 95% CI: -1.56, 1.96, P = 0.83), although few studies assessed this endpoint. Potential publication bias was identified for MDI (Eggers P = 0.005), but not other endpoints. Significant differences in findings were not identified by world region, race, maternal education, age at outcome assessment, supplementation duration, DHA or EPA dose, DHA:AA ratio, or study quality score (P-interaction > 0.05 each). Conclusions:n-3 PUFA supplementation improves childhood psychomotor and visual development, without significant effects on global IQ later in childhood, although the latter conclusion is based on fewer studies.

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Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial.

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Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial.

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