SBIR Phase I: Novel Infant Feeding System for Breastfeeding Support and Biofeedback Analysis

SBIR 第一阶段：用于母乳喂养支持和生物反馈分析的新型婴儿喂养系统

• 批准号: 2052173
• 负责人: Lauren Wright
• 金额: $ 25.6万
• 依托单位: NATURAL NIPPLE CORP., THE
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-15 至 2022-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2052173&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Infant; Feeding

The broader impact of this Small Business Innovation Research (SBIR) Phase I project will address the primary cause of the premature cessation of breastfeeding. Globally, this issue causes 820,000 deaths in children under the age of five and costs the United States over $300 billion in preventable medical costs annually. By creating an infant feeding system designed for seamless and stress-free breast and bottle feeding, with the only nipple that is researched and designed to mimic a mother’s shape, feel, and flow, this project can offer families bottle to breast continuity-reducing latching problems while promoting breastfeeding. In accordance with the market demand found in customer discovery, this project will supply the first bottle to come with tele-health support for the breastfeeding journey and immuno-biome feedback with remote stool sampling and microbiome data driven insights to support families on how to feed their child best during the first three years of life. By combining remote tele-health and immuno-biome testing services, this integrative model improves access to preventative care while providing bio-feedback insights that can save the U.S. economy an additional $10B annually. The proposed project addresses the gap in the $114 billion global baby and femtech industry, where 92% of parents who introduce a baby to a bottle are unable to return to breastfeeding for the recommended two years. The majority of women do not continue breastfeeding after 3 months after introducing a bottle when maternity leave ends. In the hospital, preterm infants are invariably exposed to nipples unnaturally fast milk flow, resulting in infant hypoxia, bradycardia, and long term neurological defects. This problem costs hospitals approximately $50 million annually by increasing consultation and length of stay costs. The proposed technology will mimic unique maternal nipple geometry and evolutionary milk flow specifically with regard to dynamic infant suckling pressures. The technical objectives of initial lab testing are to ensure the prototypes closely replicate the mother’s nipple, in terms of shape and volumetric flow rate, the silicone thickness, the media density, and the proprietary, dynamic valve diaphragm. Initial non-inferiority testing will measure if the project reduces latching problems for mothers after discharge, decreases complications for preterm patients, and the daily $3,000 per preterm infant cost to hospitals associated with flow rate of standard nipples in a quarter-long study.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

小企业创新研究 (SBIR) 第一阶段项目的更广泛影响将解决过早停止母乳喂养的主要原因。在全球范围内，这一问题导致 82 万名五岁以下儿童死亡，每年给美国造成超过 3000 亿美元的可预防医疗费用。通过创建一个专为无缝、无压力母乳和奶瓶喂养而设计的婴儿喂养系统，以及唯一经过研究和设计来模仿母亲的形状、感觉和流动的奶嘴，该项目可以为家庭提供奶瓶到乳房的连续性，减少衔乳问题，同时促进母乳喂养。根据客户发现中发现的市场需求，该项目将提供第一瓶为母乳喂养之旅提供远程医疗支持的奶瓶，并通过远程粪便采样和微生物组数据驱动的见解提供免疫生物组反馈，以支持家庭如何在孩子生命的前三年最好地喂养孩子。通过结合远程远程医疗和免疫生物组测试服务，这种综合模型改善了预防性护理的可及性，同时提供生物反馈见解，每年可以为美国经济额外节省 10B 美元。该拟议项目解决了价值 1140 亿美元的全球婴儿和女性科技行业的缺口，在该行业中，92% 使用奶瓶喂养婴儿的父母无法在建议的两年内恢复母乳喂养。大多数女性在产假结束后使用奶瓶 3 个月后不再继续母乳喂养。在医院里，早产儿总是会因乳头不自然地快速流奶而暴露，导致婴儿缺氧、心动过缓以及长期的神经缺陷。由于增加了咨询和住院时间的费用，这个问题每年给医院造成约 5000 万美元的损失。所提出的技术将模仿独特的母亲乳头几何形状和进化的乳汁流动，特别是在动态婴儿吸吮压力方面。初始实验室测试的技术目标是确保原型在形状和体积流量、硅胶厚度、介质密度以及专有的动态阀门隔膜方面紧密复制母亲的乳头。初始非劣效性测试将衡量该项目是否减少出院后母亲的衔乳问题、减少早产患者的并发症，以及在为期四分之一的研究中与标准乳头流量相关的每个早产儿每天 3,000 美元的医院费用。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。