Core Data Necessary for Reporting Clinical Trials on Nutrition in Infancy

Koletzko, Berthold; Fewtrell, Mary; Gibson, Robert A.; Goudoever, Johannes B. van; Hernell, Olle; Shamir, Raanan; Szajewska, Hania

doi:10.1159/000365766

Cited by 6 publications

(4 citation statements)

References 11 publications

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“…Main baseline characteristics of included subjects are described in Table 1 and Additional file 1 [ 19 , 20 ]. 70.0 % (21/30) of infants had IgE-mediated CMA.…”

Section: Resultsmentioning

confidence: 99%

Tolerance and growth in children with cow’s milk allergy fed a thickened extensively hydrolyzed casein-based formula

et al. 2016

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BackgroundIn case of cow’s milk allergy (CMA), pediatric guidelines recommend for children the use of extensively hydrolyzed formulas (eHFs) as elimination diet. According to the American Academy of Pediatrics, the hypoallergenicity of each specific eHF should be tested in subjects with CMA.MethodsA prospective, multicenter trial was performed to assess the tolerance/hypoallergenicity of a thickened casein-based eHF (eHCF, Allernova AR®, United Pharmaceuticals, France) in infants aged <12 months with CMA proven by a double-blind placebo-controlled food challenge. Its efficacy, measured through allergy symptoms monitoring and Cow’s Milk-related Symptom Score (CoMiSS) calculation, and safety were evaluated during a 4-month feeding period. Growth z-scores were computed based on WHO anthropometric data.ResultsThirty infants (mean age: 4.8 ± 3.0 months) with CMA proven by a DBPCFC tolerated the eHCF during the 4-month study. The CoMiSS, crying and regurgitation scores significantly decreased by 4.2 ± 4.0, 0.9 ±1.2 and 0.7 ± 1.1 respectively, after 14 days of feeding (p < 0.001). The Scoring Atopic Dermatitis index, of 33.2 ± 14.8 at inclusion in 9 patients, significantly decreased by 15.5 ± 6.7 and 21.1 ± 11.2, after 14 and 45 days of feeding, respectively (p < 0.001). The percentage of infants having normal stool consistency (soft or formed stools) significantly improved from 66.7 % (20/30) at inclusion to 90.0 % (27/30) after 14 days of feeding (p = 0.020). The growth z-scores, negative at study inclusion, significantly improved over the 4-month study. No adverse event was related to the eHCF.ConclusionThe thickened eHCF was tolerated by more than 90 % of included allergic infants with 95 % confidence interval and can therefore be considered as hypoallergenic in accordance with current guidelines. The improvement of growth indices and absence of related adverse events confirmed its safety. Results of this trial back the use of the tested thickened eHCF as an efficient and safe alternative in children with CMA.Trial registrationClinicalTrials.gov, number NCT02351531, registered on 27 January 2015Electronic supplementary materialThe online version of this article (doi:10.1186/s12887-016-0637-3) contains supplementary material, which is available to authorized users.

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“…Main baseline characteristics of included subjects are described in Table 1 and Additional file 1 [ 19 , 20 ]. 70.0 % (21/30) of infants had IgE-mediated CMA.…”

Section: Resultsmentioning

confidence: 99%

Tolerance and growth in children with cow’s milk allergy fed a thickened extensively hydrolyzed casein-based formula

et al. 2016

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“…During the baseline visit, standardized interviews were conducted in order to obtain core data (infant, maternal, parental, and ''allergic'' home environment) as recommended by European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) (22,23).…”

Section: Study Proceduresmentioning

confidence: 99%

Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth

Ahrens

Hellmuth

Haiden

et al. 2018

J. pediatr. gastroenterol. nutr.

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“…Full enteral feeds are reported as secondary outcome at 120 mL/kg/d instead of 150 or 160 mL/kg/d as recommended by the COMMENT (Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials) group. Their core data set was developed based on a previous proposal by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition 33. A rationale for choosing 120 mL/kg/d over higher amounts of milk may be the fluid restriction of infants for non-nutrition–related reasons to below 150 mL/kg/d (less likely below 120 mL/kg/d) so the time to reach 150 mL/kg/d may be delayed until fluid restriction is ceased.…”

Section: Discussionmentioning

confidence: 99%

The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): a protocol for a randomised controlled trial

et al. 2019

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IntroductionSmell and taste of milk are not generally considered when tube feeding preterm infants. Preterm infants have rapid growth, particularly of the brain, and high caloric needs. Enteral feeding is often poorly tolerated which may lead to growth failure and long-term neurodevelopmental impairment. Smell and taste are strong stimulators of digestion and metabolism. We hypothesise that regular smell and taste during tube feeding will improve weight z-scores of very preterm infants at discharge from hospital.Methods and analysisTaste is a randomised, unblinded two-centre trial. Infants born at <29 weeks’ gestation and/or <1250 g at birth and admitted to a participating neonatal intensive care unit are eligible. Randomisation occurs before infants receive two hourly feeds for 24 hours. Infants are randomised to either smell and taste of milk with each tube feed or tube feeding without the provision of smell and taste. The primary outcome is weight z-score at discharge. Secondary outcomes include: days to full enteral feeds, duration of parenteral nutrition, rate of late-onset sepsis, post menstrual age at removal of nasogastric tube and at discharge from hospital, anthropometric data and neurodevelopmental outcomes at 2 years of corrected age.Ethics and disseminationHuman Research Ethics Committees of Mater Misericordiae (trial reference number: HREC/16/MHS/112) and the Royal Women’s Hospital (trial reference number: 17/21) last approved the trial protocol (version 4.2; Date: 18 December 2018) and recruitment commenced in May 2017 and November 2017, respectively. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences.Trial registration numberACTRN12617000583347.

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Core Data Necessary for Reporting Clinical Trials on Nutrition in Infancy

Cited by 6 publications

References 11 publications

Tolerance and growth in children with cow’s milk allergy fed a thickened extensively hydrolyzed casein-based formula

Tolerance and growth in children with cow’s milk allergy fed a thickened extensively hydrolyzed casein-based formula

Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth

The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): a protocol for a randomised controlled trial

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