Use of Nfant(R) Technology Feeding System As An Adjunct To Visual Assessment And Cue-Based Feedings For Infants Born Less Than 30 Weeks Gestational Age (GA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of participants with decreased Feeding Related Length of Stay
研究概览
简要总结
The purpose of the study is to utilize the objective data provided by the nfant® suite of products, along with current NICU visual assessment and cue-based feeding practices, in order to determine if feeding performance outcomes and clinical decision making for individualized feeding plans for premature infants born less than 30 weeks PMA are impacted.
详细描述
Will obtain 5 official readings using the nfant(R) technology: baseline between 31 0/7 weeks and 32 0/7 weeks Post-Menstrual Age (PMA) with No Flow nipple, Cue-Based Feeding Readiness Reading with No Flow nipple no sooner than 33 0/7 weeks PMA, Post-Sequencing Reading with Extra Slow Flow nipple, Slow Flow nipple Reading, and Standard nipple Reading. The technology will also be utilized between readings 2 to 3 times a week. Phone Follow-up 2 question survey will be administered 21 days after discharge from Neonatal Intensive Care Unit.This survey entails routine questions regarding re-admission, to clarify if readmission was within 21 days of discharge, and if the reason for re-admission was feeding related.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 22 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants less than or equal to 29 6/7 weeks gestation at birth
排除标准
- •Infants 30 weeks or greater gestation at birth
- •Infants with known or suspected congenital anomalies or chromosomal abnormalities
- •Infants with diagnoses known to interfere with oral feeding, including, but not limited to cleft lip. cleft palate, gastroschisis, Tracheoesophageal fistula, micrognathia.
- •History of Intraventricular hemorrhage Grade 3 or 4 or Periventricular Leukomalacia
- •Infants with known diagnoses known to interfere with Gastrointestinal absorption, including, but not limited to, Necrotizing Enterocolitis requiring surgical intervention
研究组 & 干预措施
nfant(R) feeding system
Addition of nfant(R) technology, along with visual assessments and cue-based feeding practices, to facilitate an infant's progression to full oral feeding and potentially improve developmentally supportive feeding practices.
干预措施: nfant(R) feeding system (Device)
结局指标
主要结局
Number of participants with decreased Feeding Related Length of Stay
时间窗: up to 48 hours
Starts when an infant can take 5 ml of breast milk or formula orally with autonomic stability
Number of participants with Full oral feeding
时间窗: 33 weeks through study completion, an average of 1 year
Gestational age at which the infant first completes 90% of minimal ordered volumes without requiring gavage feeds for a 24 hour period
Number of participants with increased Sucking Smoothness
时间窗: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Number of participants with increased Sucking Frequency
时间窗: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS
时间窗: Neonatal Intensive Care Unit admit through study completion, an average of 1 year
Swallow Studies
Number of participants with hospital readmission for feeding related issues
时间窗: Within the first 21 days after Neonatal Intensive Care Unit discharge
Phone Follow-up
Number of participants with increased Sucking Amplitude
时间窗: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Number of participants with increased Sucking Duration
时间窗: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Number of participants with increased Sucking Efficiency
时间窗: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
次要结局
未报告次要终点