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Effect of Tube Feeding on Gastroesophageal Reflux in Preterm Infants (FT-GER-SO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837627
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2016
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Ospedale dei Bambini "V. Buzzi", Milano
Information provided by (Responsible Party):
Luigi Corvaglia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.


Condition or disease Intervention/treatment
Gastroesophageal Reflux Other: Tube feeding

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Different Modalities of Enteral Tube Feeding (ETF) on Gastroesophageal Reflux (GER) in Symptomatic Preterm Infants
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Increase/reduction in the frequency of pH-MII GERs [ Time Frame: 24 hours ]
    changes in the number of acid, non-acid, liquid and gaseous refluxes


Secondary Outcome Measures :
  1. Increase/reduction in the duration of pH-MII GERs [ Time Frame: 24 hours ]
    Changes in the duration of GERs recorded

  2. Increase/reduction in the esophageal height reached by MII GERs [ Time Frame: 24 hours ]
    Changes in the height reached by MII GERs



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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Due to the exploratory nature of this study, at least 30 preterm infants fulfilling the inclusion criteria will be enrolled.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Newborns with serious chronic pathology.
  • Ongoing pharmacological treatment that could interfere with gastro-enteral motion functions (pro-kinetics) and/or with gastric acidity (H2 antagonists; proton pump inhibitors; sodium alginate).
  • Major congenital malformations (e.g. congenital heart diseases, gastrointestinal abnormalities, malformation syndromes).
  • Neonatal necrotizing enterocolitis.
  • Ongoing infections.
  • Patients with severe clinical conditions that can hinder their participation in this trial (e.g. patent ductus arteriosus, intra-ventricular hemorrhage, hemodynamic instability).
  • Administration of experimental medication treatments during the previous two weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837627


Locations
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Italy
Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital
Bologna, Italy, 40138
SC Neonatologia e Terapia Intensiva Neonatale, Ospedale dei Bambini "V. Buzzi"
Milano, Italy
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Ospedale dei Bambini "V. Buzzi", Milano
Investigators
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Principal Investigator: Luigi T Corvaglia, Prof. Neonatal Intensive Care Unit, S.Orsola-Malpighi University Hospital, Bologna (Italy)
Publications of Results:

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Responsible Party: Luigi Corvaglia, Associate Professor, Responsible of the Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02837627    
Other Study ID Numbers: SO-2016-TF
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Luigi Corvaglia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
gastroesophageal reflux
tube enteral feeding
preterm infants
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases