Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants
Comparison of NNS Performance Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants Using the NTrainer Device
研究概览
地位
条件
详细说明
Fifteen minutes before feeding, the mobile NTrainer recording station will be positioned cribside. Following a brief exam of physiologic state, using the Oral Feeding Readiness Assessment portion of the EFS, the infant will be cradled in a supportive inclined posture, swaddled, with limbs positioned at midline, and background/overhead lighting dimmed in the area to promote eye contact with the tester. Sampling of NNS behavior will not be initiated until the infant is in an optimal behavioral state, i.e., drowsy to active alert (state 3 or 4 or 5 as described by the Naturalistic Observation of Newborn Behavior, Newborn Individualized Developmental Care and Assessment Program; NIDCAP). The infant will be presented with the NTrainer pacifier, and several contiguous 30-second blocks of NNS nipple compression data will be sampled using the NeoSuck RT software. The infant will remain connected to the usual NICU monitors at all times for observation of respiration, heartbeat and oxygen saturation.
After the NTrainer data collection is completed, the baby will be fed by his or her nurse or parents as directed in the care plan. If the baby is able to feed by mouth, one of the investigators will observe the feeding, and perform 1) a NOMAS evaluation during the first 2 minutes of the feeding, and 2) an EFS assessment after the feeding is completed.
Infants will be studied in 2 sessions each day beginning at Day 4 to 7 of life, then twice weekly (2 sessions per day, 2 days per week) until hospital discharge.
研究类型
注册 (实际的)
联系人和位置
学习地点
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North Carolina
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Raleigh、North Carolina、美国、27610
- WakeMed
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Born at 30 to 36 weeks gestation and have no exclusion criteria.
Exclusion Criteria:
- Significant birth defects.
- Breathing difficulties severe enough to require being on a ventilator or nasal CPAP for more than 2 hours after birth.
- Any oxygen requirement at Day 4 of life.
- Any neurologic problems, including seizures or frequent apnea spells.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Infants born at 30 to 36 weeks gestation
Infants will be considered eligible if they are born at 30 to 36 weeks gestation and have no exclusion criteria.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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To describe NNS pressure waveforms and NNS-STI values in normal premature infants with gestational ages 30 to 36 weeks during the first week of life.
大体时间:First Weeks of Life
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First Weeks of Life
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次要结果测量
结果测量 |
大体时间 |
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To describe the progression of NNS waveform pattern and NNS-STI values in normal premature infants as they mature to term postmenstrual age.
大体时间:Mature to full term postmenstrual age
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Mature to full term postmenstrual age
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合作者和调查者
调查人员
- 首席研究员:Thomas Young, MD、WakeMed Health and Hospitals
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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早产的临床试验
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University Hospitals Cleveland Medical CenterThe Cleveland Clinic; MetroHealth Medical Center招聘中早产 | 怀孕早产 | 舞会(怀孕) | 怀孕舞会 | PROM,早产(怀孕) | Premat Rupture Membranes Preterm 未指定破裂/分娩之间的时间长度美国