Effects of Non-nutritive Sucking on Gastroesophageal Reflux, Apneas and Bradycardias in Symptomatic Preterm Infants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in GER pH-MII features during NNS periods
研究概览
简要总结
Gastro-esophageal reflux (GER) is a common condition among preterm infants, due to several physiological promoting factors. To limit the potentially harmful widespread of pharmacological treatment, a step-wise approach, which firstly applies 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 represent an effective measure to reduce GER features in symptomatic preterm babies, whereas feed thickening is almost ineffective. Non-nutritive sucking (NNS) is a care strategy largely applied in the Neonatal Intensive Care Unit (NICU) settings. The act of swallowing is both reported to trigger the onset of transient lower esophageal sphincter relaxations (TLESRs), thereby eliciting to GER episodes, and to promote the esophageal clearance of refluxate. Hence, a possible effect of NNS on GER features might be hypothesized.
This observational, prospective and explorative study primarily aims to explore the effect of NNS, applied by means of a pacifier, on acid and non-acid GER features, evaluated in symptomatic preterm infants (gestational age ≤32 weeks) undergoing a diagnostic combined pH and multiple intraluminal impedance (pH-MII). The secondary aim of this study is to evaluate, in the subgroup of patients with recurrent GER-related apneas, the effect of NNS on cardiorespiratory events, defined as bradycardias and total, central, obstructive, mixed apneas and detected by a simultaneous polysomnographic monitoring.
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, such as apnoeas or bradycardia, the most common in the preterm population. Particularly, apneic episodes are inversely related to the gestational age (GA) and might be associated with such pathological events as hypoxia, hypercapnia or pressure variability, which seem to negatively affect the long-term neurological development of preterm babies.
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 babies. Moreover, thanks to its multichannel probe, combined pH-MII 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 NICUs. The provision of anti-histamine2 (H2) blockers and proton pump inhibitors (PPI) 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 dietetic interventions represent 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
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Days 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm newborns (GA ≤ 32 weeks) able to sustain a feeding of at least 100 ml kg-1 day-1 of fortified human milk or standard preterm formula, affected by severe/moderate GER symptomatology (recurrent regurgitations, feeding difficulties, failure to thrive and/or post-prandial desaturations) which usual treatment includes 24h pH-MII diagnostic evaluation.
- •Preterm newborns able to sustain pacifier usage for at least 2h, as scheduled in our study plan.
- •Weight ≥ 1100 g at the time of enrollment
- •Obtained written parental consent.
排除标准
- •Newborns with serious chronic pathology.
- •Ongoing pharmacological treatment which could interfere with gastro-enteral motion functions (pro-kinetics) and/or with acid gastric secretion (H2 antagonists; proton pump inhibitors).
- •Major congenital malformations (e.g. congenital heart diseases, gastrointestinal abnormalities, malformation syndromes).
- •Neonatal necrotizing enterocolitis (NEC).
- •Ongoing infections.
- •Patients with severe clinical conditions which can hinder his/her participation in this trial (e.g. patent ductus arteriosus, intra-ventricular hemorrhage, hemodynamic instability).
- •Administration of experimental medication treatment during the previous two weeks.
结局指标
主要结局
Changes in GER pH-MII features during NNS periods
时间窗: 24 hours
次要结局
- Changes in the number of cardiorespiratory events occurring during NNS periods(6 hours)
研究者
Luigi Corvaglia
Assistant Professor, University of Bologna (Italy); NICU Medical Director
IRCCS Azienda Ospedaliero-Universitaria di Bologna