Effect of Different Modalities of Enteral Tube Feeding (ETF) on Gastroesophageal Reflux (GER) in Symptomatic Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Increase/reduction in the frequency of pH-MII GERs
研究概览
简要总结
Due to several promoting factors, gastro-esophageal reflux (GER) is very frequent in preterm infants. To limit the potentially harmful widespread of pharmacological treatment, a step-wise approach, which firstly undertakes conservative strategies, is currently considered the best choice to manage GER in the preterm population. Among the most common conservative strategies, postural measures seem to effectively reduce GER features in symptomatic preterm babies, whereas feed thickening is almost ineffective.
Due to their prematurity, preterm infants <34 weeks gestation are often unable to coordinate sucking, swallowing and breathing, thus requiring a feeding tube to ensure adequate enteral intakes. Continuous feeding and boluses are the most common techniques of enteral tube feeding in Neonatal Intensive Care Units; at present, however, the effects of these techniques on GER features have not been clearly established.
This observational, prospective and explorative study primarily aims to evaluate the effect of different techniques of enteral tube feeding on GER frequency and features in symptomatic preterm infants (gestational age ≤33 weeks) undergoing a diagnostic combined pH and multiple intraluminal impedance (pH-MII) for GER evaluation.
详细描述
Due to several promoting factors related to the physiological immaturity of the gastro-intestinal tract, gastro-esophageal reflux (GER) is a frequent condition among preterm infants.
GER clinical presentation may vary within a wide range of symptoms, being vomiting, regurgitations and cardiorespiratory events the most common in the preterm population.
Combined pH and multiple intraluminal impedance (pH-MII) is currently considered the best choice for GER diagnosis in preterm infants. While pH monitoring is limited to the detection of acid reflux, combined pH-MII effectively identifies both acid and non-acid GER, which is predominant in preterm infants. Moreover, it allows to evaluate the height reached by the refluxate within the esophageal lumen and to distinguish retrograde fluid bolus movements (reflux) from the anterograde ones (swallows).
In the last decade, GER pharmacological treatment has increasingly widespread in Neonatal Intensive Care Units (NICUs). The provision of anti-histamine2 blockers and proton pump inhibitors in the preterm population, however, might lead to such adverse effects as an increased incidence of necrotizing enterocolitis and infections. Hence, to avoid a useless and potentially harmful pharmacological overtreatment, a step-wise approach, firstly promoting conservative strategies, is currently considered the most advisable choice for GER management in symptomatic preterm infants.
Postural and dietary interventions are the most common conservative strategies and their efficacy in improving GER symptoms and features has been largely investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Week 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm newborns (≤ 33 weeks gestation), able to tolerate at least 100 ml kg-1 day-1 of fortified human milk or standard preterm formula, affected by severe/moderate GER symptoms (recurrent regurgitations, feeding difficulties, failure to thrive and/or post-prandial desaturations), whose usual treatment includes a 24-h pH-MII diagnostic evaluation.
- •Need for tube feeding at the time of pH-MII
- •Weight ≥ 1100 g at the time of enrollment
- •Obtained written parental consent.
排除标准
- •Newborns with serious chronic pathology.
- •Ongoing pharmacological treatment that could interfere with gastro-enteral motion functions (pro-kinetics) and/or with gastric acidity (H2 antagonists; proton pump inhibitors; sodium alginate).
- •Major congenital malformations (e.g. congenital heart diseases, gastrointestinal abnormalities, malformation syndromes).
- •Neonatal necrotizing enterocolitis.
- •Ongoing infections.
- •Patients with severe clinical conditions that can hinder their participation in this trial (e.g. patent ductus arteriosus, intra-ventricular hemorrhage, hemodynamic instability).
- •Administration of experimental medication treatments during the previous two weeks.
结局指标
主要结局
Increase/reduction in the frequency of pH-MII GERs
时间窗: 24 hours
changes in the number of acid, non-acid, liquid and gaseous refluxes
次要结局
- Increase/reduction in the esophageal height reached by MII GERs(24 hours)
- Increase/reduction in the duration of pH-MII GERs(24 hours)
研究者
Luigi Corvaglia
Associate Professor, Responsible of the Neonatal Intensive Care Unit
IRCCS Azienda Ospedaliero-Universitaria di Bologna