Cold milk as a novel therapy for dysphagia in preterm infants

冷牛奶作为早产儿吞咽困难的新疗法

• 批准号: 10378455
• 负责人: Nazeeh N Hanna
• 金额: $ 23.1万
• 依托单位: NYU LONG ISLAND SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-28 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10378455
• 关键词: Adolescence; Adult; Adverse effects; Age; Animals; Area; Assessment tool; Axilla; Birth; Blood flow; Bolus Infusion; Brain Stem; Breast Feeding; Breathing; Bronchopulmonary Dysplasia; Caring; Cations; Childhood; Chronic; Clinical Trials; Country; Cranial Nerves; Data; Deglutition; Deglutition Disorders; Development; Diagnosis; Disease; Disease Progression; Doppler Ultrasound; Enteral Feeding; Enzymes; Evaluation; Feeds; Food; Functional disorder; Gestational Age; Grant; Human Milk; Infant; Infant formula; Inflammatory; Intervention; Intestines; Kinetics; Lead; Length of Stay; Link; Liquid substance; Lung; Medical; Medical Care Costs; Milk; Monitor; Morbidity - disease rate; Movement; Neonatal Intensive Care Units; Operative Surgical Procedures; Oral; Oropharyngeal; Penetration; Pharmacotherapy; Pharyngeal structure; Premature Infant; Publications; Publishing; Reflex action; Research; Risk; Safety; Sensory; Sensory Receptors; Severities; Stimulus; Stomach; Stress; System; Techniques; Temperature; Therapeutic; Therapeutic Intervention; Thermoreceptors; Very Low Birth Weight Infant; Visceral Afferents; clinical practice; cold temperature; effectiveness evaluation; effectiveness validation; evidence base; feeding; improved; lung injury; neonatal outcome; neonate; novel therapeutics; oral motor; respiratory; response; success; sucking

Although improvement of medical care has saved many very low birth weight (VLBW) infants who otherwise may have died, it also resulted in more infants with increased morbidities including bronchopulmonary dysplasia (BPD) and swallowing dysfunction (dysphagia). Once preterm infants approach 34 weeks postmenstrual age, oral feeding is initiated, since delayed initiation has been linked to numerous medical and developmental consequences. On the other hand, initiation of oral feeding in VLBW infants before the full maturation of their swallowing mechanisms can lead to aspiration into the lungs. Chronic aspiration results in a persistent inflammatory state, with disease progression to chronic lung injury and BPD that can be devastating for already fragile and developmentally immature lungs in preterm infants. It is estimated that 30-70% of VLBW preterm infants will have dysphagia. In spite of such a significant problem, there are limited therapeutic options for dysphagia management in VLBW infants during oral feeding. Available interventions in adults, such as pharmacotherapy and surgical interventions, are rarely an option in neonates. One alternate technique in adults is to use cold foods to stimulate a safer swallow. The use of cold stimulation activates a greater number of thermo-receptors within the oro-pharynx which consequently provides larger levels of input to the swallowing centers in the brainstem and results in improved feeding and swallowing movements. In adults, the use of cold liquids has been associated with a significant reduction in airway penetration and aspiration. However, the use of cold milk as a therapeutic option in preterm infants with dysphagia has not been evaluated leaving clinicians with very limited therapeutic options. The significant lack of dysphagia research in preterm infants hinders any evidence-based approach to such a common and substantial problem. The objective of this application is to identify preliminary evidence of the efficacy and safety of cold milk feeding for dysphagia management in VLBW infants. We hypothesize that oral feeding of cold milk in VLBW infants with dysphagia will improve suck/swallow/breathe coordination and decrease penetration and aspiration to the airway. We further hypothesize that cold milk intervention will have no adverse effects. In Aim 1 we will evaluate the effectiveness of cold milk to improve penetration/aspiration in VLBW preterm infants with dysphagia and in Aim 2, we will evaluate the safety of oral feeding of cold milk in preterm infants. To the best of our knowledge, there are no current published studies exploring the use of cold milk as a potential therapeutic intervention for dysphagia in VLBW infants. Success in our proposed studies will set the stage for a larger clinical trial that may change the paradigm of dysphagia management in preterm infants. Use of cold milk feeding will provide clinicians with a novel therapy that can impact clinical practice in NICUs throughout the country, thereby reducing the associated negative consequences of dysphagia, decreasing the length of stay, decreasing medical costs, and improving neonatal outcomes.

虽然医疗保健的改善挽救了许多极低出生体重（VLBW）婴儿，否则他们可能会死亡，但也导致更多的婴儿发病率增加，包括支气管肺发育不良（BPD）和吞咽功能障碍（吞咽困难）。一旦早产儿接近经后34周，就开始经口喂养，因为延迟开始喂养与许多医学和发育后果有关。另一方面，在极低出生体重婴儿吞咽机制完全成熟之前开始经口喂养可导致吸入肺部。慢性吸入导致持续的炎症状态，疾病进展为慢性肺损伤和BPD，这对早产儿已经脆弱和发育不成熟的肺可能是毁灭性的。据估计，30-70%的极低出生体重早产儿会有吞咽困难。尽管有这样一个重大的问题，有有限的治疗选择，吞咽困难的管理VLBW婴儿在经口喂养。成人可用的干预措施，如药物治疗和手术干预，很少用于新生儿。成人的一种替代技术是使用冷食物来刺激更安全的吞咽。冷刺激的使用激活了 口咽内的更多数量的热感受器，其因此向脑干中的吞咽中心提供更大水平的输入，并导致改善的进食和吞咽运动。在成人中，使用冷液体与气道渗透和吸入的显著减少有关。然而，使用冷牛奶作为治疗选择早产儿吞咽困难尚未进行评估，使临床医生的治疗选择非常有限。早产儿吞咽困难研究的显著缺乏阻碍了对这种常见和实质性问题的任何循证方法。本申请的目的是确定冷牛奶喂养对极低出生体重婴儿吞咽困难管理的有效性和安全性的初步证据。我们假设，在极低出生体重的婴儿吞咽困难，口服冷牛奶喂养将改善吸吮/吞咽/呼吸协调，并减少渗透和吸入气道。我们进一步假设，冷牛奶干预不会有不良影响。在目标1中，我们将评价冷牛奶改善极低出生体重早产儿吞咽困难的渗透/误吸的有效性，在目标2中，我们将评价早产儿口服冷牛奶的安全性。 据我们所知，目前尚无已发表的研究探索使用冷牛奶作为VLBW婴儿吞咽困难的潜在治疗干预。我们所提出的研究的成功将为更大规模的临床试验奠定基础，这可能会改变早产儿吞咽困难管理的模式。使用冷牛奶喂养将为临床医生提供一种新的治疗方法，可以影响全国NICU的临床实践，从而减少吞咽困难的相关负面后果，缩短住院时间，降低医疗成本，改善新生儿结局。