Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position for Feeding Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Infant physiologic responses to the feeding position - Respiratory rate (RR)
研究概览
简要总结
The objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. As an exploratory aim, the investigators will also identify potential infant characteristics associated with the intervention response by evaluating infant sex, maturity level, and/or comorbidity. The two bottle-feeding positions will be the semi-elevated side-lying position (hereafter referred to as side-lying position) and the semi-elevated supine position (hereafter referred to as supine position), which is the traditional feeding position when preterm infants are bottle-fed. The investigators hypothesize that compared to the supine position, the side-lying position will be associated with greater physiologic stability in heart rate, respiratory rate, oxygen saturation, and/or autonomic nervous system regulation during and after feeding. The investigators also hypothesize that compared to the supine position, the side-lying position will be associated with more mature patterns of suck-breathe coordination and/or greater feeding skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants who are born at ≤ 35 weeks of GA
排除标准
- •Congenital anomaly that may interfere with feeding (e.g., cleft palate or tracheoesophageal fistula)
- •Grade IV intraventricular hemorrhage
- •Ventilator-dependence beyond 60 days of life
- •Inability to orally feed prior to discharge
结局指标
主要结局
Infant physiologic responses to the feeding position - Respiratory rate (RR)
时间窗: Up to 30 minutes post-feeding
RR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)
时间窗: Up to 30 minutes post-feeding
SCOR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Heart rate variability (HRV)
时间窗: Up to 30 minutes post-feeding
HRV will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Heart rate (HR)
时间窗: Up to 30 minutes post-feeding
HR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)
时间窗: Up to 30 minutes post-feeding
SaO2 will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant behavioral responses to the feeding position - Infant feeding skill
时间窗: 5-30 minutes post-baseline
Infant behavioral responses will be assessed by the behavioral observation of infant feeding skill using the Early Feeding Skills (EFS) assessment tool.
Infant behavioral responses to the feeding position - Suck-breathe coordination
时间窗: 5-30 minutes post-baseline
Infant behavioral responses will be assessed by the behavioral observation of suck-breathe coordination patterns using Suck-Breath Coordination coding scheme.
次要结局
- Infant characteristics associated with the intervention response - Infant's sex(At enrollment)
- Infant characteristics associated with the intervention response - Overall severity of illness(At discharge, up to 150 days)
- Infant characteristics associated with the intervention response - Maturity level(At the end of the feeding observation, up to 30 minutes post-feeding)
- Infant characteristics associated with the intervention response - Severity of lung disease(At discharge, up to 150 days)