NCT02469597

Brief Summary

The purpose of this study is to assess if administration of an early single dose of a diuretic (furosemide) to children with moderate to severe bronchiolitis can reduce extravascular lung water in an effort to reduce respiratory rate, retractions, intubations, and length of stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 12, 2016

Completed
Last Updated

August 12, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

May 24, 2015

Results QC Date

June 30, 2016

Last Update Submit

June 30, 2016

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (4)

  • Respiratory Rate

    2 hours after medication adminstration

  • Respiratory Rate

    4 hours after medication adminstration

  • Oxygen Saturation

    2 hours after medication adminstration

  • Oxygen Saturation

    4 hours after medication adminstration

Secondary Outcomes (2)

  • Patient Needing Endotracheal Intubation

    Within 72 hours of medication administration

  • Length of Hospital Stay

    Participants will be followed for the duration of hospital stay up to 1 week

Study Arms (2)

Single Dose of Furosemide

EXPERIMENTAL

Furosemide 1 dose

Drug: Furosemide

Placebo

PLACEBO COMPARATOR

Normal saline 1 dose

Drug: Placebo

Interventions

FurosemideDRUG

1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose

Also known as: Lasix
Single Dose of Furosemide
PlaceboDRUG

0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose

Placebo

Eligibility Criteria

AgeUp to 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of Acute Bronchiolitis
  • Admission required per Emergency Department Physician

You may not qualify if:

  • No legal guardian present
  • Sulfa allergy
  • Patient currently on existing diuretic therapy
  • Tracheostomy
  • Mild respiratory distress (not requiring admission)
  • Hypotension / Hemodynamic Instability (defined by age specific criteria at time of intervention)
  • Supplemental Oxygen at home
  • History of Dialysis / Renal Disease
  • Those enrolled in another drug interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

Related Publications (13)

  • Pelletier AJ, Mansbach JM, Camargo CA Jr. Direct medical costs of bronchiolitis hospitalizations in the United States. Pediatrics. 2006 Dec;118(6):2418-23. doi: 10.1542/peds.2006-1193.

    PMID: 17142527BACKGROUND

  • Baker MD. Pitfalls in the use of clinical asthma scoring. Am J Dis Child. 1988 Feb;142(2):183-5. doi: 10.1001/archpedi.1988.02150020085035.

    PMID: 3341321BACKGROUND

  • Farias JA, Fernandez A, Monteverde E, Flores JC, Baltodano A, Menchaca A, Poterala R, Panico F, Johnson M, von Dessauer B, Donoso A, Zavala I, Zavala C, Troster E, Pena Y, Flamenco C, Almeida H, Nilda V, Esteban A; Latin-American Group for Mechanical Ventilation in Children. Mechanical ventilation in pediatric intensive care units during the season for acute lower respiratory infection: a multicenter study. Pediatr Crit Care Med. 2012 Mar;13(2):158-64. doi: 10.1097/PCC.0b013e3182257b82.

    PMID: 21725275BACKGROUND

  • Hernando Puente M, Lopez-Herce Cid J, Bellon Cano JM, Villaescusa JU, Santiago Lozano MJ, Sanchez Galindo A. [Prognostic factors for bronchiolitis complications in a pediatric intensive care unit]. An Pediatr (Barc). 2009 Jan;70(1):27-33. doi: 10.1016/j.anpedi.2008.08.004. Epub 2008 Nov 25. Spanish.

    PMID: 19174116BACKGROUND

  • National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

    PMID: 16714767BACKGROUND

  • Rush MG, Engelhardt B, Parker RA, Hazinski TA. Double-blind, placebo-controlled trial of alternate-day furosemide therapy in infants with chronic bronchopulmonary dysplasia. J Pediatr. 1990 Jul;117(1 Pt 1):112-8. doi: 10.1016/s0022-3476(05)82458-8.

    PMID: 2196353BACKGROUND

  • Stewart A, Brion LP. Intravenous or enteral loop diuretics for preterm infants with (or developing) chronic lung disease. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD001453. doi: 10.1002/14651858.CD001453.pub2.

    PMID: 21901676BACKGROUND

  • Hagadorn JI, Sanders MR, Staves C, Herson VC, Daigle K. Diuretics for very low birth weight infants in the first 28 days: a survey of the U.S. neonatologists. J Perinatol. 2011 Oct;31(10):677-81. doi: 10.1038/jp.2011.11. Epub 2011 Mar 10.

    PMID: 21394079BACKGROUND

  • Green TP. The pharmacologic basis of diuretic therapy in the newborn. Clin Perinatol. 1987 Dec;14(4):951-64.

    PMID: 3322632BACKGROUND

  • Hufnagle KG, Khan SN, Penn D, Cacciarelli A, Williams P. Renal calcifications: a complication of long-term furosemide therapy in preterm infants. Pediatrics. 1982 Sep;70(3):360-3.

    PMID: 7110808BACKGROUND

  • Ross BS, Pollak A, Oh W. The pharmacologic effects of furosemide therapy in the low-birth-weight infant. J Pediatr. 1978 Jan;92(1):149-52. doi: 10.1016/s0022-3476(78)80098-5.

    PMID: 22591BACKGROUND

  • Ghanekar AG, Das Gupta V, Gibbs CW Jr. Stability of furosemide in aqueous systems. J Pharm Sci. 1978 Jun;67(6):808-11. doi: 10.1002/jps.2600670621.

    PMID: 660463BACKGROUND

  • Williamson K, Bredin G, Avarello J, Gangadharan S. A Randomized Controlled Trial of a Single Dose Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis. J Emerg Med. 2018 Jan;54(1):40-46. doi: 10.1016/j.jemermed.2017.08.099. Epub 2017 Nov 23.

    PMID: 29174754DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Furosemide

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Limitations and Caveats

The trial was ended early due to recruitment difficulties.

Results Point of Contact

Title
Dr. Kristy Williamson
Organization
Northwell Health- Cohen Children's Medical Center
kwilliam12@nshs.edu
718-470-7640

Study Officials

  • Sandeep Gangadharan, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

May 24, 2015

First Posted

June 11, 2015

Study Start

October 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 12, 2016

Results First Posted

August 12, 2016

Record last verified: 2016-06

Locations

US(1)