We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189149
First Posted: August 26, 2010
Last Update Posted: February 6, 2013
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.
Information provided by (Responsible Party):
Bnai Zion Medical Center
  Purpose
Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.

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

Study Type: Interventional
Study Design: 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

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 35
Study Start Date: December 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: August 23, 2010
First Posted: August 26, 2010
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