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

NCT ID: NCT01189149

Last Updated: 2013-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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Conditions

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Viral Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IV fluids

Infants will get IV fluids whem indicated until able to tolerate full oral feedings

Group Type EXPERIMENTAL

IV fluids

Intervention Type PROCEDURE

Infants will be allocated to IV fluids

Oro/naso gastric tube feeding

Infants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings

Group Type EXPERIMENTAL

Naso/oro gastric tube feedings

Intervention Type PROCEDURE

Infants will be allocated to naso/oro gastric tube feedings

Interventions

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IV fluids

Infants will be allocated to IV fluids

Intervention Type PROCEDURE

Naso/oro gastric tube feedings

Infants will be allocated to naso/oro gastric tube feedings

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amir Kugelman, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Locations

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Pediatric Department

Haifa, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 23260101 (View on PubMed)

Other Identifiers

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115/08

Identifier Type: -

Identifier Source: org_study_id

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