Clinical Trial: Effect of Tube Feeding on Gastroesophageal Reflux in Preterm Infants
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational
Official Title: Effect of Different Modalities of Enteral Tube Feeding (ETF) on Gastroesophageal Reflux (GER) in Symptomatic Preterm Infants
Brief Summary:
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.
Detailed Summary:
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.
As previously assessed by pH-MII, both prone and left-side positions were more effective than the righ
Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Current Primary Outcome: Increase/reduction in the frequency of pH-MII GERs [ Time Frame: 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Increase/reduction in the duration of pH-MII GERs [ Time Frame: 24 hours ]
- Increase/reduction in the esophageal height reached by MII GERs [ Time Frame: 24 hours ]
Original Secondary Outcome: Same as current
Information By: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Dates:
Date Received: February 7, 2016
Date Started: December 2015
Date Completion: February 2019
Last Updated: April 1, 2017
Last Verified: April 2017
