Quantitation of Oral-Motor Function in Infants

描述（由申请人提供）：背景：喂养问题在超过50%的早产儿、耳鼻喉科功能障碍或中枢神经系统损伤（以后可能表现为脑瘫）的婴儿中很常见。它们可能导致生长不良、无法茁壮成长、反复住院，并带来重大的诊断和管理挑战。最严重的[>1：1000]需要广泛的评估;但除了X线或减肥研究，临床工具是视觉和定性的，仍然可以留下未解决的问题。Orometer是一种连接到普通婴儿奶瓶的新型设备，旨在通过直观的图形输出量化婴儿的营养吸吮，可以共享和交换，方便专业咨询。没有可比工具可用。在一项I期SBIR研究中，我们在测试一小群正常婴儿时取得了成功的结果。假设：即使在潜在病因可能显现之前，也有可能量化和表征此类喂养问题。这些信息将具有临床价值。具体目标：在200名正常足月婴儿和200名潜在异常婴儿中进行Orometer的临床试验，以建立正常婴儿和风险婴儿的基本orometric参数。长期计划：开发Orometer用于婴儿喂养问题的常规临床评估。将Orometer授权给制造商进行最终产品开发和销售。研究设计：在前6个月内对200名正常足月婴儿进行两次测试，以确定当时发生的成熟变化是否可以检测和量化。对另外200名婴儿进行测试：30名正常的早产儿在前3个月内进行两次测试，另外170名有喂养问题或发育迟缓的婴儿或有这种风险的婴儿在转诊时和一年后再次进行测试，以确定他们的记录是否与正常模式不同，以及最初的研究是否可以正确识别出那些后来有发育问题的婴儿。相关性：如果成功，Orometer将有助于分期喂养，从而加快高危婴儿从NICU出院。这也将是预后和治疗价值的婴儿口腔运动功能障碍，包括那些未确诊的神经发育困难，或那些注定要表现为脑瘫以后。早期认识到具体的喂养问题，应导致更早和更好的喂养策略，从而导致早期出院，并更好地治疗长期残疾的婴儿。商业潜力：NICU、发育诊所、喂养专家和儿科医生的潜在销售量预计为3000-8000/5年。

DESCRIPTION (provided by applicant): Background: Feeding problems are common in infants occurring in over 50% of those with prematurity, oropharngyeal dysfunction, or central nervous system injury [that may manifest later as cerebral palsy]. They can lead to poor growth, failure-to-thrive, recurrent hospitalization and present major diagnostic and management challenges. The most severe [>1:1000] require extensive evaluations; but apart from X-ray or bariatric studies, the clinical tools are visual and qualitative that still can leave unresolved questions. The Orometer is a novel device that attaches to a normal infant feeding bottle, designed to quantify nutritive sucking by infants with intuitive graphical output that can be shared and exchanged, facilitating professional consultations. No comparable instrument is available. In a phase I SBIR study, we showed successful results in testing a small cohort of normal infants. Hypothesis: It is possible to quantify and characterize such feeding problems even before an underlying etiology may be manifest. Such information would be of clinical value. Specific Aim: To conduct a clinical trial of the Orometer in 200 normal full term, and 200 potentially abnormal infants to establish basic orometric parameters in both normal and infants at risk. Long Term Plan: To develop the Orometer for routine clinical evaluation of feeding problems in infants. To license the Orometer to a manufacturer for final product development and sale. Study design: Test 200 normal full-term infants twice in the first 6 months to determine if the maturational changes occurring at that time can be detected and quantified. Test another 200 infants: 30 normal preterm infants twice in the first 3 months, and 170 others with, or at risk of having, feeding problems or delayed development, at referral and again at one year to determine whether their records differ from the normal patterns, and whether the initial study could identify correctly those infants with later developmental problems. Relevance: If successful, the Orometer would be useful in staging feeding, and thus expedite discharge of high-risk infants from NICUs. It would also be of prognostic and therapeutic value for infants with oral-motor dysfunction, including those with undiagnosed neurodevelopmental difficulties, or those destined to manifest cerebral palsy later. Early recognition of specific feeding problems should lead to earlier and better feeding strategies thus leading to earlier discharge and to better treatment of infants with long term disabilities. Commercial Potential: Potential sales to NICUs, developmental clinics, feeding specialists and pediatricians are projected in the 3000-8000/5years range.