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Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis

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ClinicalTrials.gov Identifier: NCT01189149
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Viral Bronchiolitis Procedure: IV fluids Procedure: Naso/oro gastric tube feedings

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial
Study Start Date : December 2008
Primary Completion Date : March 2012
Study Completion Date : March 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: IV fluids
Infants will get IV fluids whem indicated until able to tolerate full oral feedings
Procedure: IV fluids
Infants will be allocated to IV fluids
Experimental: Oro/naso gastric tube feeding
Infants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings
Procedure: Naso/oro gastric tube feedings
Infants will be allocated to naso/oro gastric tube feedings


Outcome Measures

Primary Outcome Measures :
  1. Clinical outcomes [ Time Frame: 3 winters ]
    Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.


Secondary Outcome Measures :
  1. Possible side effects of each method (IV vs. Oro/nasogastric feedings) [ Time Frame: 3 winters ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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): NCT01189149


Locations
Israel
Pediatric Department
Haifa, Israel
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Amir Kugelman, MD Bnai Zion Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01189149     History of Changes
Other Study ID Numbers: 115/08
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: December 2009

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases