NCT07049900招募中不适用
Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in thickness of the rectus abdominis muscle
研究概览
简要总结
The primary outcome of this study is to determine if the use of the FDA-approved DandleLion NeoBellyBand increases the thickness of the rectus abdominis muscle in premature babies receiving continuous positive pressure ventilation, leading to infants reaching full oral feedings at an earlier corrected gestational age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 22 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature viable neonates with corrected gestational age of 22-31 weeks
- •Anticipated to require non-invasive continuous positive pressure ventilation including bCPAP, CPAP, and NAVA CPAP for a minimum of 2 weeks either on their first trial of CPAP or after extubation.
排除标准
- •Outside of gestational age at birth
- •Umbilical lines
- •Genetic condition or neuromuscular anomaly
- •Known abdominal anomaly
- •Non-viable neonates and neonates with uncertain viability who are not anticipated to be able to survive with standard NICU care.
- •Surgical intervention on the abdominal wall, such as gastroschisis or history of surgical NEC
- •Compromised skin integrity of abdominal wall
- •Any condition in the opinion of the investigator that would risk the data integrity or collection of the study
研究组 & 干预措施
NeoBelllyBand
Active Comparator
Infants in this group will continue to have standard NICU care, with the addition of wearing the NeoBellyBand device while they remain on CPAP.
干预措施: NeoBelly Band (Device)
Standard NICU Care
No Intervention
Infants in this group will receive standard neonatal intensive unit care as defined by the University of Minnesota Masonic Children's Hospital NICU protocol.
结局指标
主要结局
Change in thickness of the rectus abdominis muscle
时间窗: 8 weeks
Thickness measured by ultrasound
次要结局
未报告次要终点
研究者
研究点 (2)
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