Lindsey Otten, Antonia Nomayo, Caroline Gunn, Maher Fuad, Barbara Kuhn-Sherlock, Sophie Gallier, Elisabeth Schelker, Janine Foster, Frank Jochum
{"title":"企鹅研究:一项随机、双盲、对100%部分水解乳清蛋白婴儿配方奶粉安全性和适用性的等效试验。","authors":"Lindsey Otten, Antonia Nomayo, Caroline Gunn, Maher Fuad, Barbara Kuhn-Sherlock, Sophie Gallier, Elisabeth Schelker, Janine Foster, Frank Jochum","doi":"10.3390/pediatric17020045","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background/Objectives:</b> This study aimed to demonstrate the safety and suitability of an infant formula manufactured from partially hydrolysed whey protein (PHF) compared to standard formula manufactured from intact cow's milk proteins (IPF; whey-casein ratio, 60:40) in healthy term infants. <b>Methods:</b> This multicentre, randomised, double-blinded, placebo-controlled trial included infants of mothers who intended to exclusively formula feed. Infants ≤ 28 days of age received PHF or IPF for at least 90 and up to 180 days. A group of exclusively breastfed infants was included for reference. The safety evaluation consisted of an equivalence analysis of weight gain within +/-3 g/d after 90 days, further growth parameters, and adverse events. <b>Results:</b> Of the 249 infants randomised, 143 (76 IPF; 67 PHF), as well as 45 breastfed infants, completed the study per protocol. The mean difference in daily weight gain between the formula groups was within the equivalence margins (-2.4 g/d (95% CI 0.3-4.5)) with estimated means (SEM) of 34.9 (0.78) g/d (IPF) and 32.5 (0.76) g/d (PHF). No significant differences in weight gain, length, and head circumference or in the number, severity, or type of adverse events were observed. Comparable growth patterns were observed in the breastfed group. <b>Conclusions:</b> The PHF is safe and supports adequate infant growth with a daily weight gain non-inferior to a standard IPF.</p>","PeriodicalId":45251,"journal":{"name":"Pediatric Reports","volume":"17 2","pages":""},"PeriodicalIF":1.4000,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12030296/pdf/","citationCount":"0","resultStr":"{\"title\":\"The Penguin Study: A Randomised, Double-Blinded, Equivalence Trial on the Safety and Suitability of an Infant Formula with Partially Hydrolysed 100% Whey Protein.\",\"authors\":\"Lindsey Otten, Antonia Nomayo, Caroline Gunn, Maher Fuad, Barbara Kuhn-Sherlock, Sophie Gallier, Elisabeth Schelker, Janine Foster, Frank Jochum\",\"doi\":\"10.3390/pediatric17020045\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Background/Objectives:</b> This study aimed to demonstrate the safety and suitability of an infant formula manufactured from partially hydrolysed whey protein (PHF) compared to standard formula manufactured from intact cow's milk proteins (IPF; whey-casein ratio, 60:40) in healthy term infants. <b>Methods:</b> This multicentre, randomised, double-blinded, placebo-controlled trial included infants of mothers who intended to exclusively formula feed. Infants ≤ 28 days of age received PHF or IPF for at least 90 and up to 180 days. A group of exclusively breastfed infants was included for reference. The safety evaluation consisted of an equivalence analysis of weight gain within +/-3 g/d after 90 days, further growth parameters, and adverse events. <b>Results:</b> Of the 249 infants randomised, 143 (76 IPF; 67 PHF), as well as 45 breastfed infants, completed the study per protocol. The mean difference in daily weight gain between the formula groups was within the equivalence margins (-2.4 g/d (95% CI 0.3-4.5)) with estimated means (SEM) of 34.9 (0.78) g/d (IPF) and 32.5 (0.76) g/d (PHF). No significant differences in weight gain, length, and head circumference or in the number, severity, or type of adverse events were observed. 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引用次数: 0
摘要
背景/目的:本研究旨在证明由部分水解乳清蛋白(PHF)制成的婴儿配方奶粉与由完整牛奶蛋白(IPF)制成的标准配方奶粉的安全性和适用性。乳清-酪蛋白比,60:40)健康足月婴儿。方法:这项多中心、随机、双盲、安慰剂对照的试验纳入了纯配方喂养的母亲所生的婴儿。≤28日龄的婴儿接受PHF或IPF治疗至少90天和最多180天。一组纯母乳喂养的婴儿被纳入参考。安全性评估包括90天后体重增加+/-3 g/d的等效分析、进一步的生长参数和不良事件。结果:在249例随机分组的婴儿中,143例(76例IPF;67名PHF)以及45名母乳喂养的婴儿按照方案完成了研究。配方奶组之间的日增重平均差异在等效范围内(-2.4 g/d (95% CI 0.3-4.5)),估计平均值(SEM)为34.9 (0.78)g/d (IPF)和32.5 (0.76)g/d (PHF)。在体重增加、体长和头围或不良事件的数量、严重程度或类型方面没有观察到显著差异。在母乳喂养组中观察到类似的生长模式。结论:PHF是安全的,支持足够的婴儿生长,每日体重增加不低于标准IPF。
The Penguin Study: A Randomised, Double-Blinded, Equivalence Trial on the Safety and Suitability of an Infant Formula with Partially Hydrolysed 100% Whey Protein.
Background/Objectives: This study aimed to demonstrate the safety and suitability of an infant formula manufactured from partially hydrolysed whey protein (PHF) compared to standard formula manufactured from intact cow's milk proteins (IPF; whey-casein ratio, 60:40) in healthy term infants. Methods: This multicentre, randomised, double-blinded, placebo-controlled trial included infants of mothers who intended to exclusively formula feed. Infants ≤ 28 days of age received PHF or IPF for at least 90 and up to 180 days. A group of exclusively breastfed infants was included for reference. The safety evaluation consisted of an equivalence analysis of weight gain within +/-3 g/d after 90 days, further growth parameters, and adverse events. Results: Of the 249 infants randomised, 143 (76 IPF; 67 PHF), as well as 45 breastfed infants, completed the study per protocol. The mean difference in daily weight gain between the formula groups was within the equivalence margins (-2.4 g/d (95% CI 0.3-4.5)) with estimated means (SEM) of 34.9 (0.78) g/d (IPF) and 32.5 (0.76) g/d (PHF). No significant differences in weight gain, length, and head circumference or in the number, severity, or type of adverse events were observed. Comparable growth patterns were observed in the breastfed group. Conclusions: The PHF is safe and supports adequate infant growth with a daily weight gain non-inferior to a standard IPF.