CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Tube feedingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02837627
NCT02837627N/ACompleted

Effect of Different Modalities of Enteral Tube Feeding (ETF) on Gastroesophageal Reflux (GER) in Symptomatic Preterm Infants

IRCCS Azienda Ospedaliero-Universitaria di Bologna·observational·Posted Jul 19, 2016·Updated Aug 14, 2023

In Brief

An observational study evaluating Tube feeding for Gastroesophageal Reflux. Completed, enrolled 31 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 19, 2016
Enrollment StartJan 1, 2016
Primary CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 10.0 years ago

Interventions

Tube feedingother

During the study period, enteral feeds will be administered according to different tube feeding modalities: bolus feeding followed by the removal of the feeding tube; bolus tube feeding with permanence of the feeding tube for the whole post-prandial period; continuous feeding over a 3-hour period.