Effects of Vented Base Feeding Bottle in Preterm Infants With GERD Symptoms. (FeedGERD)
|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: NCT03031288|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : March 31, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|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|
Experimental: Start feeding with Device A, "standard"
Alternatively feeding with standard feeding bottle (Device A) and vented base feeding 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)
vented base bottle
- 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)
- 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
- 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
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
|Ospedale S.Anna di Torino|
|Torino, (to), Italy, 10126|
|Principal Investigator:||Francesco Cresi, MD PhD||University of Turin, Italy|