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临床试验/NCT06736743
NCT06736743已完成不适用

Review of Infant Oral Feeding and Skills Study

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Capable Feeding Skills at Discharge

研究概览

简要总结

This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral feeding.

详细描述

Situation: Feeding Problems in Infancy

Feeding problems are a frequent complication for infants in the neonatal intensive care unit (NICU), with an estimated 80% of infants experiencing feeding difficulties during their NICU stay. Inadequate oral feeding (by volume) is one of the most common reasons for prolonged NICU stays. Feeding problems are common reasons for hospital readmission in the moderate and late preterm population. In a large multicenter retrospective study of premature infants born before 33 weeks gestation, less than 4% were discharged from NICU with feeding tubes (nasogastric or gastrostomy) for severe feeding problems. However, in the pediatric setting, a meta-analysis found that 42% of premature infants born before 37 weeks had ongoing feeding problems before four years of age. The 10x difference in the prevalence of feeding problems in NICU and pediatric settings implies that infants either have inadequate feeding skills at discharge or develop them later at home. The disparity in the literature begs the question of whether clinicians are adequately assessing feeding skill development in the NICU setting.

In severe cases, feeding problems in childhood cause immense stress to the child and family at mealtime. Pediatric Feeding Disorder (PFD) is defined as impaired oral intake that is not age-appropriate and is associated with medical, nutritional, feeding skills, and/or psychosocial dysfunction. While a skill-based approach to treating PFD is essential in the pediatric world, skill-based information is not fully appreciated in the NICU.

Background: Skill Based Feeding

Feeding management is central to the baby's physiological balance, growth, behavioral display of pleasure, and a nurturing relationship with the parent. The acquisition of safe and efficient nipple-feeding skills is a complex task and one of the most challenging milestones for most preterm or high-risk infants to achieve. Premature infants are at higher risk of feeding problems compared to term infants due to 1. Innate differences in muscle tone, state regulation, endurance, and suck-swallow-breathing coordination; 2. Disruption of in utero brain development due to decreased myelination and white matter disturbances, and 3. They have higher nutritional requirements per kilogram body weight than term infants and are less tolerant of high fluid volumes. Similarly, full-term infants with complex conditions and syndromes may have altered anatomy, physiology and neurodevelopment, which impact oral feeding.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
22 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Neonates admitted and discharged from Advocate Illinois Masonic Medical Center (AIMMC) Neonatal Intensive Care Unit (NICU) from April 1, 2024 to September 30, 2024

排除标准

  • •Discharged without attaining full independent oral feeds by volume. This excludes infant deaths and transfers without attaining full oral feeds.

研究组 & 干预措施

NICU Infants

One cohort of infants who were admitted and discharged during the study period.

干预措施: SMART Tool for Feeding Skill Assessment (Diagnostic Test)

结局指标

主要结局

Capable Feeding Skills at Discharge

时间窗: At discontinuation of SMART Tool Scoring for up to 6 months.

Based on the Last Feeding Skill Assessment (FSA) Score, calculate the percentage of infants in the "capable" range/ total included infants. The SMART tool evaluates feeding skills across five domains: State of arousal, motor tone, autonomic instability, response to stimulation, and total oral skills. The score has a minimum value of 25 and a maximum value of 100; higher scores mean a better outcome. The post-feed SMART Tool score classifies the infant feeding skills into three categories: caution (25 to 60), developing (60 to 90), and capable (91 to 100).

次要结局

  • Feeding Skills Distribution at Discharge.(At discontinuation of SMART Tool Scoring for up to 6 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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