Publications by authors named "Deolinda M F Scalabrin"

9 Publications

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International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol.

BMC Pregnancy Childbirth 2019 Aug 7;19(1):282. Epub 2019 Aug 7.

Maternal-Infant Studies Center (CEMI), San Juan, Puerto Rico.

Background: Until recently, Zika virus (ZIKV) infections were considered mild and self-limiting. Since 2015, they have been associated with an increase in microcephaly and other birth defects in newborns. While this association has been observed in case reports and epidemiological studies, the nature and extent of the relationship between ZIKV and adverse pregnancy and pediatric health outcomes is not well understood. With the unique opportunity to prospectively explore the full spectrum of issues related to ZIKV exposure during pregnancy, we undertook a multi-country, prospective cohort study to evaluate the association between ZIKV and pregnancy, neonatal, and infant outcomes.

Methods: At research sites in ZIKV endemic regions of Brazil (4 sites), Colombia, Guatemala, Nicaragua, Puerto Rico (2 sites), and Peru, up to 10,000 pregnant women will be recruited and consented in the first and early second trimesters of pregnancy and then followed through delivery up to 6 weeks post-partum; their infants will be followed until at least 1 year of age. Pregnant women with symptomatic ZIKV infection confirmed by presence of ZIKV RNA and/or IgM for ZIKV will also be enrolled, regardless of gestational age. Participants will be tested monthly for ZIKV infection; additional demographic, physical, laboratory and environmental data will be collected to assess the potential interaction of these variables with ZIKV infection. Delivery outcomes and detailed infant assessments, including physical and neurological outcomes, will be obtained.

Discussion: With the emergence of ZIKV in the Americas and its association with adverse pregnancy outcomes in this region, a much better understanding of the spectrum of clinical outcomes associated with exposure to ZIKV during pregnancy is needed. This cohort study will provide information about maternal, fetal, and infant outcomes related to ZIKV infection, including congenital ZIKV syndrome, and manifestations that are not detectable at birth but may appear during the first year of life. In addition, the flexibility of the study design has provided an opportunity to modify study parameters in real time to provide rigorous research data to answer the most critical questions about the impact of congenital ZIKV exposure.

Trial Registration: NCT02856984 . Registered August 5, 2016. Retrospectively registered.
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August 2019

Reduction of Arachidonate Is Associated With Increase in B-Cell Activation Marker in Infants: A Randomized Trial.

J Pediatr Gastroenterol Nutr 2017 03;64(3):446-453

*Alberta Institute for Human Nutrition, University of Alberta †Alberta Health Services, Edmonton AB, Canada ‡Clinical Research, Mead Johnson Nutrition, Evansville, IN, the Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT §Ophthalmology and Visual Sciences, University of Alberta ||Department of Pediatrics, Alberta Health Services, Edmonton AB ¶Department of Pediatrics, University of British Columbia, Vancouver BC, Canada.

Background: Infants who are not breast-fed benefit from formula with both docosahexaenoic acid (C22:6n3) and arachidonic acid (ARA; C20:4n6). The amount of ARA needed to support immune function is unknown. Infants who carry specific fatty acid desaturase (FADS) polymorphisms may require more dietary ARA to maintain adequate ARA status.

Objective: The aim of the study was to determine whether ARA intake or FADS polymorphisms alter ARA levels of lymphocytes, plasma, and red blood cells in term infants fed infant formula.

Methods: Infants (N = 89) were enrolled in this prospective, double-blind controlled study. Infants were randomized to consume formula containing 17 mg docosahexaenoic acid and 0, 25, or 34 mg ARA/100 kcal for 10 weeks. Fatty acid composition of plasma phosphatidylcholine and phosphatidylethanolamine, total fatty acids of lymphocytes and red blood cells, activation markers of lymphocytes, and polymorphisms in FADS1 and FADS2 were determined.

Results: Lymphocyte ARA was higher in the 25-ARA formula group than in the 0- or 34-ARA groups. In plasma, 16:0/20:4 and 18:0/20:4 species of phosphatidylcholine and phosphatidylethanolamine were highest and 16:0/18:2 and 18:0/18:2 were lowest in the 34-ARA formula group. In minor allele carriers of FADS1 and FADS2, plasma ARA content was elevated only at the highest level of ARA consumed. B-cell activation marker CD54 was elevated in infants who consumed formula containing no ARA.

Conclusions: ARA level in plasma is reduced by low ARA consumption and by minor alleles in FADS. Dietary ARA may exert an immunoregulatory role on B-cell activation by decreasing 16:0/18:2 and 18:0/18:2 species of phospholipids. ARA intake from 25 to 34 mg/100 kcal is sufficient to maintain cell ARA level in infants across genotypes.
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March 2017

Formula with long-chain polyunsaturated fatty acids reduces incidence of allergy in early childhood.

Pediatr Allergy Immunol 2016 Mar 21;27(2):156-61. Epub 2016 Jan 21.

University of Kansas Medical Center, Kansas City, KS, USA.

Background: Allergy has sharply increased in affluent Western countries in the last 30 years. N-3 long-chain polyunsaturated fatty acids (n-3 LCPUFAs) may protect the immune system against development of allergy.

Methods: We prospectively categorized illnesses by body system in a subset of 91 children from the Kansas City cohort of the DIAMOND (DHA Intake and Measurement of Neural Development) study who had yearly medical records through 4 years of age. As infants, they were fed either a control formula without LCPUFA (n = 19) or one of three formulas with LCPUFA from docosahexaenoic acid (DHA) and arachidonic acid (ARA) (n = 72).

Results: Allergic illnesses in the first year were lower in the combined LCPUFA group compared to the control. LCPUFAs significantly delayed time to first allergic illness (p = 0.04) and skin allergic illness (p = 0.03) and resulted in a trend to reduced wheeze/asthma (p = 0.1). If the mother had no allergies, LCPUFAs reduced the risk of any allergic diseases (HR = 0.24, 95% CI = 0.1, 0.56, p = 0.0.001) and skin allergic diseases (HR = 0.35, 95% CI = 0.13, 0.93, p = 0.04). In contrast, if the mother had allergies, LCPUFAs reduced wheezing/asthma (HR = 0.26, 95% CI = 0.07, 0.9, p = 0.02).

Conclusions: LCPUFA supplementation during infancy reduced the risk of skin and respiratory allergic diseases in childhood with effects influenced by maternal allergies.
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March 2016

Infants fed formula with added long chain polyunsaturated fatty acids have reduced incidence of respiratory illnesses and diarrhea during the first year of life.

BMC Pediatr 2014 Jul 2;14:168. Epub 2014 Jul 2.

Department of Medical Affairs, Clinical Research, Mead Johnson Nutrition, Evansville, USA.

Background: Long chain polyunsaturated fatty acids (LCPUFAs) may influence the immune system. Our objective was to compare the frequency of common illnesses in infants who received formula with or without added LCPUFAs.

Methods: In this observational, multi-center, prospective study, infants consumed formula with 17 mg DHA and 34 mg ARA/100 kcal (n = 233) or with no added DHA or ARA (n = 92). Pediatricians recorded respiratory illnesses, otitis media, eczema, and diarrhea through 1 year of age.

Results: Infants who consumed formula with DHA/ARA had lower incidence of bronchitis/bronchiolitis (P = 0.004), croup (P = 0.044), nasal congestion (P = 0.001), cough (P = 0.014), and diarrhea requiring medical attention (P = 0.034). The odds ratio (OR) of having at least one episode of bronchitis/bronchiolitis (0.41, 95% CI 0.24, 0.70; P = 0.001), croup (0.23, 95% CI 0.05, 0.97; P = 0.045), nasal congestion (0.37, 95% CI 0.20, 0.66; P = 0.001), cough (0.52, 95% CI 0.32, 0.86; P = 0.011), and diarrhea requiring medical attention (0.51, 95% CI 0.28, 0.92; P = 0.026) was lower in infants fed DHA/ARA. The OR of an increased number of episodes of bronchitis/bronchiolitis, croup, nasal congestion, cough, and diarrhea, as well as the hazard ratio for shorter time to first episode of bronchitis/bronchiolitis, nasal congestion, cough, and diarrhea were also significantly lower in the DHA/ARA group.

Conclusions: In healthy infants, formula with DHA/ARA was associated with lower incidence of common respiratory symptoms and illnesses, as well as diarrhea.
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July 2014

Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial.

BMJ Open 2012 5;2(2):e000637. Epub 2012 Mar 5.

The Food Allergy Referral Centre, Department of Pediatrics, Veneto Region, Università degli Studi di Padova, Padova, Italy.

Objective: To evaluate the hypoallergenicity of an extensively hydrolysed (EH) casein formula supplemented with Lactobacillus rhamnosus GG (LGG).

Design: A prospective, randomised, double-blind, placebo-controlled crossover trial.

Setting: Two study sites in Italy and The Netherlands.

Study Participants: Children with documented cow's milk allergy were eligible for inclusion in this trial.

Interventions: After a 7-day period of strict avoidance of cow's milk protein and other suspected food allergens, participants were tested with an EH casein formula with demonstrated hypoallergenicity (control, EHF) and a formula of the same composition with LGG added at 10(8) colony-forming units per gram powder (EHF-LGG) in randomised order in a double-blind placebo-controlled food challenge (DBPCFC). After absence of adverse reactions in the DBPCFC, an open challenge was performed with EHF-LGG, followed by a 7-day home feeding period with the same formula.

Main Outcome Measure: Clinical assessment of any adverse reactions to ingestion of study formulae during the DBPCFC.

Results: For all participants with confirmed cow's milk allergy (n=31), the DBPCFC and open challenge were classified as negative.

Conclusion: The EH casein formula supplemented with LGG is hypoallergenic and can be recommended for infants and children allergic to cow's milk who require an alternative to formulae containing intact cow's milk protein.

Trial Registration Number: Identifier: NCT01181297.
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October 2012

Stool pattern changes in toddlers consuming a follow-on formula supplemented with polydextrose and galactooligosaccharides.

J Pediatr Gastroenterol Nutr 2012 Feb;54(2):288-90

Department of Pediatrics, Fima Lifshitz Research Center, University Hospital Complex Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil.

Healthy 9- to 48-month-old children (n = 133) were randomized to receive a cow's-milk-based follow-on formula (control) or the same formula with polydextrose and galactooligosaccharides (PDX/GOS) for 108 days. Pediatricians assessed diarrheal disease, stool pattern, acute respiratory infection, systemic antibiotic use, and growth. The 2 groups had similar weight-for-length/height z score and similar odds of having diarrheal disease, acute respiratory infection, and systemic antibiotic use; however, PDX/GOS had greater odds of increased defecation than control (P ≤ 0.01). Addition of PDX and GOS to a follow-on formula was well tolerated and induced a pattern of more frequent and softer stools in toddlers.
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February 2012

New prebiotic blend of polydextrose and galacto-oligosaccharides has a bifidogenic effect in young infants.

J Pediatr Gastroenterol Nutr 2012 Mar;54(3):343-52

Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN, USA.

Objective: The aim of the study was to evaluate the effect of infant formula with polydextrose (PDX) and galacto-oligosaccharides (GOS) on fecal microbiota and secretory IgA (sIgA).

Materials And Methods: In the present double-blind, randomized study, term infants received control (Enfamil Lipil) or the same formula with PDX/GOS (4 g/L, 1:1 ratio; PDX/GOS) for 60 days; a reference breast-fed group was included. Formula intake, tolerance, and stool characteristics were collected via electronic diary and analyzed by repeated measures analysis of variance. Anthropometric measurements and stool samples were obtained at baseline and after 30 and 60 days of feeding. Fecal sIgA was measured by enzyme-linked immunosorbent assay and fecal bacteria by fluorescent in situ hybridization and quantitative real-time polymerase chain reaction (qPCR); both were analyzed by Wilcoxon rank sum test.

Results: Two hundred thirty infants completed the study. Infants consuming PDX/GOS had softer stools than control at all times (P < 0.001). Using qPCR, counts in PDX/GOS were closer to the breast-fed group, tended to be higher than control for total bifidobacteria (P = 0.069) and Bifidobacterium longum (P = 0.057) at 30 days, and were significantly higher for total bifidobacteria and B longum at 60 days and B infantis at 30 days (P = 0.002). No significant differences were detected between PDX/GOS and control in changes from baseline to 30 or 60 days for sIgA or total bifidobacteria by fluorescent in situ hybridization or qPCR; however, significantly higher changes from baseline were detected between PDX/GOS and control for B infantis at 30 days and B longum at 60 days (P ≤ 0.035).

Conclusions: Infant formula with PDX/GOS produces soft stools and a bifidogenic effect closer to breast milk than formula without PDX/GOS.
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March 2012

Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid.

J Pediatr 2008 Aug 9;153(2):266-71. Epub 2008 Apr 9.

Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.

Objective: In study 1, to compare the effect on growth in healthy infants of a new amino acid-based formula (AAF) and a control extensively hydrolyzed formula (EHF), with both docosahexaenoic acid (DHA) and arachidonic acid (ARA) at levels similar to those in human milk worldwide. In study 2, to evaluate the hypoallergenicity of this new AAF in infants and children with confirmed cow's milk allergy (CMA).

Study Design: In study 1, a total of 165 healthy, full-term, formula-fed infants randomly received the new AAF or control formula. Anthropometric measurements, tolerance, and adverse events were recorded throughout the study. Plasma amino acid profiles were evaluated in a subset of the infants. In study 2, the hypoallergenicity of the new AAF was evaluated in 32 infants and children using a double-blind, placebo-controlled food challenge; an open challenge; and a 7-day feeding.

Results: In study 1, overall growth, tolerance, and safety outcomes were similar in both groups. In study 2, 29 of the 32 subjects completed both challenges; no allergic reaction was seen in any of the 32 subjects.

Conclusions: The new AAF with DHA and ARA at levels similar to those in human milk worldwide is hypoallergenic. It also is safe and supports growth in healthy, term infants.
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August 2008