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临床试验/NCT01666457
NCT01666457已完成不适用

The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the NICU

Ann & Robert H Lurie Children's Hospital of Chicago1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
1
主要终点
Oral Feeding Outcomes

研究概览

简要总结

The specific aim of this pre-post trial is to compare data regarding oral feeding, length of stay, and growth outcomes of 100 NICU infants to these same outcomes following the implementation of a developmentally supportive, infant driven feeding program with the NICU staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding program on a second sample of 100 NICU infants at Children's Memorial Hospital.

The specific research questions considered in this study are:

  1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term?
  2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term?
  3. What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU?
  4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU staff evaluations and communications related to managing oral feedings with medically fragile infants?

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
3 Months 至 5 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants of all gestations and diagnostic groups in this tertiary level NICU will be included in the sample

排除标准

  • Infants with medical diagnoses known to impact sucking and swallowing
  • Infants unable to manage their oral secretions
  • Infants who remain hospitalized beyond 3 months adjusted age
  • Infants who expire or are transferred to another inpatient unit or hospital/facility prior to discharge from the NICU

结局指标

主要结局

Oral Feeding Outcomes

时间窗: Up to 5 months

Infant oral feeding outcomes per structured parent phone interview at home.

Oral feeding outcomes

时间窗: Up to 3 months

Defined as percentage of ordered full feeding volume as ordered by NICU staff taken orally at NICU discharge and, if applicable, the number of days to take 100% of ordered feeding volume orally.

次要结局

  • Growth Outcomes(Up to 5 months)
  • Growth outcomes(Up to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan M Horner, MS, APN/CNS, RNC-NIC

Developmental Specialist

Ann & Robert H Lurie Children's Hospital of Chicago

研究点 (1)

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