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临床试验/NCT02030951
NCT02030951终止不适用

Measurement of Feeding Experience for Infants With Non-Oral Feedings

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
1
主要终点
Oral Feeding Difficulty

研究概览

简要总结

Feeding that circumvents the oral cavity drastically alters the infant's feeding experience (pre, intra and post feeding) and may lead to oral feeding difficulty. It is estimated that 35 - 40% of infants exhibit oral feeding difficulty. Consequences include delayed oral feeding, growth failure, and inadequate mother-infant interaction. Behaviors related to the feeding experience include behavioral state transitions, orally directed behaviors, hunger and satiation cues, and social interactive behaviors. It is unknown whether these early behaviors differ for hospitalized infants who receive long term tube feedings when compared with infants fed orally or whether alterations in these behaviors can be early indicators of later oral feeding difficulty. Documentation of these missing or altered behaviors is needed prior to the development and testing of interventions to prevent oral feeding difficulty.

For 75 hospitalized infants with long term tube feedings, this research will: 1) describe the range of early feeding behaviors encompassing the feeding experience; 2) identify the change in early feeding behaviors throughout hospitalization; 3) compare the early feeding behaviors of infants with and without oral feeding difficulty at 12 months corrected age (CA); and 4) compare parent perception and provider assessment of feeding, for infants with and without oral feeding difficulty.

We will document infant behaviors surrounding the feeding experience during tube feedings weekly during hospital stay. Throughout the first year of life, infant growth, parent perception and clinician assessment of infant feeding and infant and maternal behavior during feeding will be evaluated to document the occurrence of oral feeding difficulty, allowing for a comparison with early in hospital feeding behaviors. To analyze for changes over time, we will use Generalized Linear Mixed Models (GLMM) for repeated count (Poisson) and frequency/categorical (logistic and multinomial logistic) outcomes (e.g., frequency of infant behaviors). Understanding the constellation of these behaviors and when they begin, will guide the development of interventions whose goal will be to alleviate the long term consequences of oral feeding difficulty, inform clinical practice, and reduce cost.

详细描述

SPECIFIC AIMS: Feeding that circumvents the oral cavity drastically alters the infant's feeding experience and may lead to oral feeding difficulty. It is estimated that 35 - 40% of infants exhibit oral feeding difficulty and 34% of infants evaluated for oral feeding difficulty develop oral feeding resistance during the first year of life. Behaviors associated with oral feeding difficulty include: unclear infant behaviors signaling hunger or satiation; the infant frequently interrupts the feeding, spitting or vomiting, or postural changes during the feeding; infant irritability; increased or decreased length of feeding; delayed acquisition of feeding skills, and disengagement during feeding. Oral feeding resistance is more severe and includes persistent food refusal >1 month, disruptive mealtime behavior, rigid food preferences, gagging in anticipation of feeding, and/or vomiting and failure to master feeding skills consistent with the child's developmental level. The consequences of oral feeding difficulty involve: delayed oral feeding, growth failure, delayed perceptual motor performance, and disengagement with the caregiver related to feeding, which leads to less optimal patterns of parent-infant interaction. It is currently unknown what the early indicators of oral feeding difficulty are or when they begin to develop. The purpose of this research is to prospectively describe early feeding and social interactive behaviors of tube fed infants prior to the later development of oral feeding difficulty and retrospectively compare differences in these behaviors in infants who exhibit oral feeding difficulty with infants not exhibiting these behaviors.

Throughout the first year of life, infant growth, parent perception of infant feeding, clinician assessment of infant feeding skills, and infant and maternal behavior during feeding will be evaluated to document the occurrence of oral feeding difficulty, allowing for a comparison of these early in hospital feeding behaviors. The study aims are to:

Aim 1: Describe the range of early feeding behaviors (pre-feeding, intra feeding, and post) and feeding progression in hospitalized infants who have long term exposure to naso-gastric, oral-gastric and gastrostomy tube feedings. Feeding behaviors are measured as behavioral states, orally directed behaviors, social interactive behaviors (engagement and disengagement behaviors), hunger and satiation cues, sucking organization, and motor activity. Feeding progression is measured as the daily change in the proportion of tube to oral intake.

Aim 2: Identify the change in early feeding behaviors throughout the infant's hospital stay.

Aim 3: Compare the early feeding behaviors of infants with and without oral feeding difficulty at 12 months corrected age (CA).

研究设计

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

入排标准

年龄范围
— 至 50 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Infant Inclusion Criteria: * prior surgical treatment for gut,
  • •chest surgery (non cardiac),
  • •or non-surgical infants who will require a minimum of 2 weeks of non-oral formula/breast milk feedings,
  • •may be receiving oxygen therapy and intravenous therapy.
  • •may have previously been treated for sepsis, pneumonia, received intravenous only intake, or managed with assisted ventilation. Maternal Inclusion criteria: *must be able to read and comprehend English. Infant

排除标准

  • •*infant receiving assisted ventilation,

结局指标

主要结局

Oral Feeding Difficulty

时间窗: 12 months of life

Oral feeding difficulty will be identified through parent self report and clinician assessment at 2,4,6, and 12 months CA.

次要结局

  • Feeding progression(over the first year of life)

研究者

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

Rosemary White-Traut

Director of Nursing Research

Medical College of Wisconsin

研究点 (1)

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