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

February 5, 2013 updated by: Bnai Zion Medical Center

Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial

Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Pediatric department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: 3 winters
Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.
3 winters

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 winters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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