Abdominal Binders to Minimize Enteral Nutrition Disruptions for Preterm Infants On Non-Invasive Respiratory Support
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Days with interruptions to the feeding protocol
研究概览
简要总结
The goal of this study is to learn if a foam belly strap, called "NeoBellyBand," can help with belly bloating, pauses in feedings, feeding success, and earlier discharge home for preterm infants who are requiring pressurized breathing support. Infants whose parents/ caregivers have consented to the study will be randomly chosen with a 50/50 chance of treatment with the NeoBellyBand or receiving standard NICU care. The main question it seeks to answer is if there are less interruptions to the feeding protocol for infants who have a NeoBellyBand placed on them compared with infants who do not. Infants on the treatment arm will have their bellies measured by trained personnel and have bands placed on them, which will be worn for most of the day while on breathing support with pressure.
详细描述
Background Preterm neonates who require respiratory support benefit from the use of non-invasive respiratory support over invasive mechanical ventilation to decrease rates of chronic lung disease [1]. Non-invasive support typically involves positive end-expiratory pressure which allows for distending pressures to keep the alveoli of the lungs open [1]. In our institution, this typically includes continuous positive airway pressure (CPAP) or non-invasive mechanical ventilation (NIMV). Mechanistically, due to the positioning of the trachea adjacent to the esophagus, the provision of pressure support for the lungs often results in additional air and pressure being supplied to the enteric tract. This can result in what is called "CPAP belly" [2]. Although CPAP belly was initially described as a benign gaseous distension, emerging evidence shows it has negative impacts on the functionality of the enteric tract, including delaying gastric emptying time [2,3]. A recent study characterizing CPAP belly has shown that it can lead to longer time to full enteral feeds, disruptions to feeding practices, and additional abdominal radiography [4].
Several strategies have been tried to decrease feeding intolerance in infants with abdominal distension, including early enteral feeds, which is our current practice, abdominal massages, and probiotic therapy [5,6]. Recently, a novel idea was proposed to combat the progression of CPAP belly: abdominal binding to support the abdominal wall musculature [7]. It was initially reported as a case study of two infants with significant abdominal distension while on respiratory support who had improvements in their distension back to expected range within one week of therapy initiation and without any reported adverse effects [7]. The author of this article has created a product, the NeoBellyBand for sale by the DandleLION Medical company, for use in her own institution. It is now in use in several institutions, given its minimal risk to patients and the potential benefits, as the new standard of care. In speaking with the developer of this product, we understand that there are also ongoing pre-and post-intervention studies looking at its impact on decreasing rates of chronic lung disease or length of stay in the NICU.
There is little published evidence for or against the use of abdominal binding in this population and there are no current studies that the research team is aware of looking at its impact on feeding practices in the NICU. Prior to the use of abdominal binding, we would like to study its safety and efficacy for the neonatal population. We hypothesize that the use of abdominal binders will lead to a decrease in feeding interruption events as well as a decrease in adverse feeding and respiratory outcomes for preterm neonates on non-invasive respiratory support.
The specific aims of this study are to:
- Evaluate the impact of abdominal binders on decreasing interruptions to our unit feeding protocol due to feeding intolerance symptoms, such as increased abdominal distension or high-volume gastric residuals, compared with our current standard of care.
- Analyze the effect of abdominal binding on time to major neonatal milestones, including discontinuation of respiratory support, discontinuation of parenteral nutrition, full oral feeds, discontinuation of therapies to promote regular stooling (such as glycerin suppositories or prune juice), and discharge from hospital.
- Determine how the use of abdominal binders changes respiratory management (such as increasing respiratory pressures for worsening distension) and respiratory outcomes (such as chronic lung disease).
- Evaluate the safety of abdominal binders by tracking possible adverse effects, including temperature regulation concerns, skin integrity concerns, and incidence and complications associated with umbilical or inguinal hernias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Year(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at <32w0d GA
- •Chronologic age >7 days, treatment or control protocol started by 21 days of life
- •On non-invasive positive pressure respiratory support (NIMV or CPAP), either as primary support or after extubation from invasive mechanical ventilation
- •Has received 80 mL/kg/day of feeds at least once
排除标准
- •Skin integrity concerns
- •Known abdominal or respiratory anomalies
- •Umbilical lines in place
- •Transferred to AMC NICU after 7 days of life
- •Known genetic or major anatomic anomalies
结局指标
主要结局
Days with interruptions to the feeding protocol
时间窗: During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).
Days with interruptions to the feeding protocol, defined as interruptions to feeds or advances per our unit protocol for the infant's GA and birth weight (BW), due to feeding intolerance, defined as abdominal distension, increase in abdominal girth, abnormal stooling pattern, abdominal tenderness, increase in gastric residuals, emesis, and feeding-related cardiorespiratory events.
次要结局
- Age at which infant first achieved 120 mL/kg/day of enteral feeds(During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).)
- Number of abdominal radiographs obtained for abdominal concerns(During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).)
- Length of hospital admission and post-menstrual age (PMA) at discharge(During initial hospitalization in the NICU after infant is enrolled in the study.)
- Post-menstrual age (PMA) when successfully off all respiratory support(During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).)
- Rates of chronic lung disease (CLD), defined as oxygen requirement at 36 weeks PMA(During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).)
- Rates of abnormal abdominal circumference (AC): head circumference (HC)(During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).)
- Post-menstrual age (PMA) at which infant achieves full oral feeds(During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).)
研究者
Anshu Paul
Assistant Professor Of Pediatrics
Albany Medical College
