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

Status: Completed
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 4 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital
Bologna
SC Neonatologia e Terapia Intensiva Neonatale, Ospedale dei Bambini V. Buzzi
Milan
Time Frame
Start Date: 2016-01-01
Completion Date: 2023-02-28
Participants
Target number of participants: 31
Sponsors
Collaborators: Ospedale dei Bambini V. Buzzi, Milano
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov