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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03053609 |
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Date of registration:
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09/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Gastroesophageal Reflux and Cardiorespiratory Problems
CR-GER |
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Scientific title:
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Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants. |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03053609 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Francesco Cresi, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Turin, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- synchronized MII-pH and cardio-respiratory monitoring lasting more than 12 hours,
excluding meal periods;
- exclusive enteral feeding
- parents' informed consent
Exclusion Criteria:
- infectious, genetic, metabolic and neurological diseases
- ventilatory support and/or oxygen supplementation at the time of MII-pH/CR monitoring
- pharmacological therapies with effects on GER or apnoea during the week before
MII-pH/CR monitoring
Age minimum:
N/A
Age maximum:
3 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastroesophageal Reflux Disease
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Bradycardia
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Desaturation of Blood
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Apnea Infants
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Primary Outcome(s)
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SAP index
[Time Frame: calculated throughout 24 hours]
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Secondary Outcome(s)
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Gastroesophageal reflux frequency
[Time Frame: calculated throughout 24 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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