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Effect of Tube Feeding on Gastroesophageal Reflux in Preterm Infants

NCT02837627 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux

Interventions

OTHER

Tube feeding

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.

Sponsors & Collaborators

  • Ospedale dei Bambini "V. Buzzi", Milano

    collaborator UNKNOWN

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Luigi T Corvaglia, Prof. · Neonatal Intensive Care Unit, S.Orsola-Malpighi University Hospital, Bologna (Italy)

Eligibility

Min Age
1 Week
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02837627 on ClinicalTrials.gov