Effects of Vented Base Feeding Bottle in Preterm Infants With GERD Symptoms.

NCT03031288 | Completed DMC

• 1 other identifier: feeding-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to evaluate the effects of vented base bottles on respiration-swallow patterns and on gastroesophageal refluxes in preterm infants with clinical suspect of gastroesophageal reflux disease (GERD). In this crossover-randomized study, we compared the effects of standard feeding bottles (A) versus vented base feeding bottles (B) on a group of patients with at least 2 clinical GERD symptoms. 24 hours of synchronized cardiorespiratory (CR) and Esophageal Multichannel intraluminal impedance (MII/pH) monitoring were evaluated for each patient. During this period, patients were fed alternatively with feeding bottle A and B.

Conditions

GERD; Apnea Neonatal

Keywords

gastroesophageal reflux; swallow; feeding bottle; cardiorespiratory; apnoea; preterm; impedance-pH-metry

Outcome Measures

Primary Outcomes (1)

• Frequency of cardiorespiratory events (feeding+postprandial time)

  Cardiorespiratory events / hour * apnea (no breathing movement for at least 20 s, or less if associated with desaturation/bradycardia) * desaturation (SpO2 \<80%) * bradycardia (heart rate \< 80 bpm for at least 1 s)

  calculated throughout 24 hour

Secondary Outcomes (2)

• Swallow event characteristics (feeding time)

  calculated throughout 30 minute interval after the beginning of the milk meal

• Frequency of reflux events (postprandial time)

  calculated throughout 150 minute interval after the end of the milk meal

Study Arms (2)

Start feeding with Device A, "standard"

EXPERIMENTAL

Alternatively feeding with standard feeding bottle (Device A) and vented base feeding bottle (Device B)

Device: A; Device: B

Start feeding with Device B, "vented"

EXPERIMENTAL

Alternatively feeding with vented base feeding bottle (Device B) and standard feeding bottle (Device A)

Device: A; Device: B

Interventions

A DEVICE

standard bottle

Start feeding with Device A, "standard"; Start feeding with Device B, "vented"

B DEVICE

vented base bottle

Start feeding with Device A, "standard"; Start feeding with Device B, "vented"

Eligibility Criteria

• Age: 1 Week - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• weight ≥ 1500 g at the time of examination
• at least 2 GERD symptoms
• exclusive enteral feeding
• parents' informed consent

You may not qualify if:

• congenital abnormalities
• perinatal asphyxia
• respiratory, genetic, metabolic, infectious and/or neurologic disease
• pharmacological therapies, in the last 7 days, able to affect esophageal motility

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Ospedale S.Anna di Torino

Torino, (TO), 10126, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Bottle Feeding; Apnea; Premature Birth

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Feeding Behavior; Behavior; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Francesco Cresi, MD PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)