Effect of Tube Feeding on Gastroesophageal Reflux in Preterm Infants (FT-GER-SO)
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|ClinicalTrials.gov Identifier: NCT02837627|
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2016
Last Update Posted : July 5, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
- 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.
- 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
- Increase/reduction in the duration of pH-MII GERs [ Time Frame: 24 hours ]Changes in the duration of GERs recorded
- Increase/reduction in the esophageal height reached by MII GERs [ Time Frame: 24 hours ]Changes in the height reached by MII GERs
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
|Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital|
|Bologna, Italy, 40138|
|SC Neonatologia e Terapia Intensiva Neonatale, Ospedale dei Bambini "V. Buzzi"|
|Principal Investigator:||Luigi T Corvaglia, Prof.||Neonatal Intensive Care Unit, S.Orsola-Malpighi University Hospital, Bologna (Italy)|