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

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ClinicalTrials.gov Identifier: NCT03031288
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Francesco Cresi, MD, PhD, University of Turin, Italy

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.


Condition or disease Intervention/treatment Phase
GERD Apnea Neonatal Device: A Device: B Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Vented Base Feeding Bottle in Preterm Infants With GERD Symptoms: Effects on Respiration-swallow Patterns and Reflux.
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Start feeding with Device A, "standard"
Alternatively feeding with standard feeding bottle (Device A) and vented base feeding bottle (Device B)
Device: A
standard bottle

Device: B
vented base bottle

Experimental: Start feeding with Device B, "vented"
Alternatively feeding with vented base feeding bottle (Device B) and standard feeding bottle (Device A)
Device: A
standard bottle

Device: B
vented base bottle




Primary Outcome Measures :
  1. Frequency of cardiorespiratory events (feeding+postprandial time) [ Time Frame: calculated throughout 24 hour ]

    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)


Secondary Outcome Measures :
  1. Swallow event characteristics (feeding time) [ Time Frame: calculated throughout 30 minute interval after the beginning of the milk meal ]
    Swallow event is identified as a rapid increase in impedance preceded by a drop in impedance to 50% of baseline beginning in the proximal channel and proceeding in an anterograde direction to the most distal channel, followed by the recovery of baseline values at each channel

  2. Frequency of reflux events (postprandial time) [ Time Frame: calculated throughout 150 minute interval after the end of the milk meal ]
    Reflux event is defined as: a drop of impedance to 50% of the basal value for at least 5 s, starting in the most distal channel and proceeding to one or more proximal channels and followed by a recovery of the impedance baseline values



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03031288


Locations
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Italy
Ospedale S.Anna di Torino
Torino, (to), Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Francesco Cresi, MD PhD University of Turin, Italy
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Responsible Party: Francesco Cresi, MD, PhD, MD PhD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT03031288    
Other Study ID Numbers: feeding-01
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francesco Cresi, MD, PhD, University of Turin, Italy:
gastroesophageal reflux
swallow
feeding bottle
cardiorespiratory
apnoea
preterm
impedance-pH-metry
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases