Back to resultsIntravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis
Primary Purpose
Viral Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IV fluids
Naso/oro gastric tube feedings
Sponsored by
About this trial
This is an interventional treatment trial for Viral Bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- Infants with bronchiolitis < 6 months who need to be hospitalized and are not able to eat per os.
Exclusion Criteria:
- Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.
Sites / Locations
- Pediatric Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IV fluids
Oro/naso gastric tube feeding
Arm Description
Infants will get IV fluids whem indicated until able to tolerate full oral feedings
Infants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings
Outcomes
Primary Outcome Measures
Clinical outcomes
Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.
Secondary Outcome Measures
Possible side effects of each method (IV vs. Oro/nasogastric feedings)
Local or systemic signs of infection, "para"infusion, discomfort while inserting the IV, electrolyte abnormalitis (as part of routine care) vs. aspiration, discomfort with naso/oro gastric tube.
Full Information
NCT ID
NCT01189149
First Posted
August 23, 2010
Last Updated
February 5, 2013
Sponsor
Bnai Zion Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01189149
Brief Title
Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis
Official Title
Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bnai Zion Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV fluids
Arm Type
Experimental
Arm Description
Infants will get IV fluids whem indicated until able to tolerate full oral feedings
Arm Title
Oro/naso gastric tube feeding
Arm Type
Experimental
Arm Description
Infants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings
Intervention Type
Procedure
Intervention Name(s)
IV fluids
Intervention Description
Infants will be allocated to IV fluids
Intervention Type
Procedure
Intervention Name(s)
Naso/oro gastric tube feedings
Intervention Description
Infants will be allocated to naso/oro gastric tube feedings
Primary Outcome Measure Information:
Title
Clinical outcomes
Description
Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.
Time Frame
3 winters
Secondary Outcome Measure Information:
Title
Possible side effects of each method (IV vs. Oro/nasogastric feedings)
Description
Local or systemic signs of infection, "para"infusion, discomfort while inserting the IV, electrolyte abnormalitis (as part of routine care) vs. aspiration, discomfort with naso/oro gastric tube.
Time Frame
3 winters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants with bronchiolitis < 6 months who need to be hospitalized and are not able to eat per os.
Exclusion Criteria:
Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Kugelman, MD
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Department
City
Haifa
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
23260101
Citation
Kugelman A, Raibin K, Dabbah H, Chistyakov I, Srugo I, Even L, Bzezinsky N, Riskin A. Intravenous fluids versus gastric-tube feeding in hospitalized infants with viral bronchiolitis: a randomized, prospective pilot study. J Pediatr. 2013 Mar;162(3):640-642.e1. doi: 10.1016/j.jpeds.2012.10.057. Epub 2012 Dec 20.
Results Reference
derived
Learn more about this trial
Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis
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