Graduate Program in Child and Adolescent Health, Universidade Federal do Rio Grande do Sul (UFRGS) Medical School, Porto Alegre, Brazil.
Neonatology Section, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.
Trials. 2021 Oct 9;22(1):687. doi: 10.1186/s13063-021-05647-1.
The traditional spoon-feeding approach to introduction of solid foods during the complementary feeding period is supported by consensus in the scientific literature. However, a method called Baby-Led Introduction to SolidS (BLISS) has been proposed as an alternative, allowing infants to self-feed with no adult interference. To date, there have been no trials in the Brazilian population to evaluate the effectiveness of BLISS in comparison to the traditional approach.
METHODS/DESIGN: To evaluate and compare three different complementary feeding methods. Data on 144 mother-child pairs will be randomized into intervention groups by methods: (A) strict Parent-Led Weaning; (B) strict Baby-Led Introduction to SolidS; and (C) a mixed method. Prospective participants from Porto Alegre, Brazil, and nearby cities will be recruited through the Internet. The interventions will be performed by nutritionists and speech therapists, at 5.5 months of age of the child, at a private nutrition office equipped with a test kitchen where meals will be prepared according to the randomized method. The pairs will be followed up at 7, 9, and 12 months of age. Data will be collected through questionnaires designed especially for this study, which will include a 24h child food recall, questionnaires on the child's and parents' eating behavior, oral habits, eating difficulties, and choking prevalence. At 12 months of age, children will undergo blood collection to measure hemoglobin, ferritin, and C-reactive protein, saliva collection for analysis of genetic polymorphisms, and oral examination. Anthropometric parameters (child and maternal) will be measured at the baseline intervention, at a 9 month home visit, and at the end-of-study visit at the hospital. The primary outcome will be child growth and nutritional status z-scores at 12 months; secondary outcomes will include iron status, feeding behavior, acceptability of the methods, dietary variety, choking, eating behaviors, food preferences, acceptance of bitter and sweet flavors, suction, oral habits, oral hygiene behavior, dental caries, gingival health status, and functional constipation.
The trial intends to ascertain whether there are potential advantages to the BLISS complementary feeding method in this specific population, generating data to support families and healthcare providers.
Brazilian Clinical Trials Registry (ReBEC): RBR- 229scm number U1111-1226-9516 . Registered on September 24, 2019.
在补充喂养期，传统的汤匙喂养方法在科学文献中得到了共识的支持。然而，有一种名为婴儿主导固体引入（Baby-Led Introduction to SolidS，BLISS）的方法被提出作为替代方法，允许婴儿自行进食，无需成人干预。迄今为止，巴西人群中还没有试验来评估 BLISS 与传统方法相比的有效性。
方法/设计：评估和比较三种不同的补充喂养方法。将 144 对母婴随机分为干预组，方法为：（A）严格的家长主导断奶；（B）严格的婴儿主导固体引入；和（C）混合方法。来自巴西阿雷格里港和附近城市的前瞻性参与者将通过互联网招募。干预措施将由营养师和语言治疗师在孩子 5.5 个月大时在配备有测试厨房的私人营养办公室进行，根据随机方法准备膳食。将在 7、9 和 12 个月时对这些对进行随访。将通过专门为此研究设计的问卷收集数据，其中包括 24 小时儿童食物回忆、儿童和父母饮食行为、口腔习惯、进食困难和窒息流行率的问卷。在 12 个月时，儿童将接受血液采集以测量血红蛋白、铁蛋白和 C 反应蛋白，唾液采集用于分析遗传多态性，以及口腔检查。在基线干预、9 个月的家庭访问和医院结束时的研究访问时，将测量儿童和母亲的人体测量参数。主要结局将是 12 个月时儿童生长和营养状况 z 评分；次要结局将包括铁状况、喂养行为、方法的可接受性、饮食多样性、窒息、进食行为、食物偏好、对苦和甜味道的接受程度、吮吸、口腔习惯、口腔卫生行为、龋齿、牙龈健康状况和功能性便秘。
该试验旨在确定 BLISS 补充喂养方法在这一特定人群中是否具有潜在优势，为家庭和医疗保健提供者提供数据支持。
巴西临床试验注册处（ReBEC）：RBR-229scm 号 U1111-1226-9516。于 2019 年 9 月 24 日注册。
