Effect of Tube Feeding on Gastroesophageal Reflux in Preterm Infants

NCT02837627 | Completed

• 1 other identifier: SO-2016-TF
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastroesophageal Reflux

Keywords

gastroesophageal reflux; tube enteral feeding; preterm infants

Outcome Measures

Primary Outcomes (1)

• Increase/reduction in the frequency of pH-MII GERs

  changes in the number of acid, non-acid, liquid and gaseous refluxes

  24 hours

Secondary Outcomes (2)

• Increase/reduction in the duration of pH-MII GERs

  24 hours

• Increase/reduction in the esophageal height reached by MII GERs

  24 hours

Interventions

Tube feeding OTHER

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.

Eligibility Criteria

• Age: 1 Week - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Ospedale dei Bambini "V. Buzzi", Milano: collaborator

Study Sites (2)

Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

SC Neonatologia e Terapia Intensiva Neonatale, Ospedale dei Bambini "V. Buzzi"

Milan, Italy

Location

Related Publications (9)

• Dhillon AS, Ewer AK. Diagnosis and management of gastro-oesophageal reflux in preterm infants in neonatal intensive care units. Acta Paediatr. 2004 Jan;93(1):88-93.

  PMID: 14989446 RESULT

• van der Pol RJ, Smits MJ, Venmans L, Boluyt N, Benninga MA, Tabbers MM. Diagnostic accuracy of tests in pediatric gastroesophageal reflux disease. J Pediatr. 2013 May;162(5):983-7.e1-4. doi: 10.1016/j.jpeds.2012.10.041. Epub 2012 Dec 7.

  PMID: 23219449 RESULT

• Wenzl TG, Moroder C, Trachterna M, Thomson M, Silny J, Heimann G, Skopnik H. Esophageal pH monitoring and impedance measurement: a comparison of two diagnostic tests for gastroesophageal reflux. J Pediatr Gastroenterol Nutr. 2002 May;34(5):519-23. doi: 10.1097/00005176-200205000-00009.

  PMID: 12050578 RESULT

• Malcolm WF, Gantz M, Martin RJ, Goldstein RF, Goldberg RN, Cotten CM; National Institute of Child Health and Human Development Neonatal Research Network. Use of medications for gastroesophageal reflux at discharge among extremely low birth weight infants. Pediatrics. 2008 Jan;121(1):22-7. doi: 10.1542/peds.2007-0381.

  PMID: 18166553 RESULT

• More K, Athalye-Jape G, Rao S, Patole S. Association of inhibitors of gastric acid secretion and higher incidence of necrotizing enterocolitis in preterm very low-birth-weight infants. Am J Perinatol. 2013 Nov;30(10):849-56. doi: 10.1055/s-0033-1333671. Epub 2013 Jan 28.

  PMID: 23359235 RESULT

• Corvaglia L, Ferlini M, Rotatori R, Paoletti V, Alessandroni R, Cocchi G, Faldella G. Starch thickening of human milk is ineffective in reducing the gastroesophageal reflux in preterm infants: a crossover study using intraluminal impedance. J Pediatr. 2006 Feb;148(2):265-8. doi: 10.1016/j.jpeds.2005.09.034.

  PMID: 16492440 RESULT

• Corvaglia L, Rotatori R, Ferlini M, Aceti A, Ancora G, Faldella G. The effect of body positioning on gastroesophageal reflux in premature infants: evaluation by combined impedance and pH monitoring. J Pediatr. 2007 Dec;151(6):591-6, 596.e1. doi: 10.1016/j.jpeds.2007.06.014. Epub 2007 Oct 24.

  PMID: 18035136 RESULT

• Aceti A, Corvaglia L, Paoletti V, Mariani E, Ancora G, Galletti S, Faldella G. Protein content and fortification of human milk influence gastroesophageal reflux in preterm infants. J Pediatr Gastroenterol Nutr. 2009 Nov;49(5):613-8. doi: 10.1097/MPG.0b013e31819c0ce5.

  PMID: 19633575 RESULT

• Corvaglia L, Aceti A, Mariani E, Legnani E, Ferlini M, Raffaeli G, Faldella G. Lack of efficacy of a starch-thickened preterm formula on gastro-oesophageal reflux in preterm infants: a pilot study. J Matern Fetal Neonatal Med. 2012 Dec;25(12):2735-8. doi: 10.3109/14767058.2012.704440. Epub 2012 Jul 13.

  PMID: 22725606 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Luigi T Corvaglia, Prof.

  Neonatal Intensive Care Unit, S.Orsola-Malpighi University Hospital, Bologna (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Responsible of the Neonatal Intensive Care Unit

Study Record Dates

• First Submitted: February 7, 2016
• First Posted: July 19, 2016
• Study Start: January 1, 2016
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

IT (2)