NCT00319956

Brief Summary

The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD. The purpose of this study is to determine if Azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

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

September 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

June 27, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

7.8 years

First QC Date

April 27, 2006

Results QC Date

July 29, 2013

Last Update Submit

June 25, 2018

Conditions

Bronchopulmonary Dysplasia

Keywords

premature infantrespiratory distress syndromemechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Incidence of Bronchopulmonary Dysplasia (BPD)

    comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups.

    diagnosis of BPD at 36wks corrected gestational age

Other Outcomes (3)

  • Postnatal Steroid Use

    Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

  • Number of Days on Mechanical Ventilation

    Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

  • Participant Mortality

    Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

Study Arms (2)

Azithromycin Group

ACTIVE COMPARATOR

Group receives azithromycin

Drug: Azithromycin

Placebo Group

PLACEBO COMPARATOR

Group receives placebo

Drug: Placebo

Interventions

AzithromycinDRUG

Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.

Also known as: zith, azith
Azithromycin Group
PlaceboDRUG

vehicle dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.

Also known as: control group
Placebo Group

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • birthweight less than 1250 grams admitted to UK NICU
  • mechanical ventilation within the first 72 hours of life

You may not qualify if:

  • confirmed sepsis by blood culture
  • multiple congenital anomalies or known syndromes
  • intrauterine growth retardation with birthweight less than 10%ile for gestational age
  • ROM for \>7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • Ballard HO, Shook LA, Bernard P, Anstead MI, Kuhn R, Whitehead V, Grider D, Crawford TN, Hayes D Jr. Use of azithromycin for the prevention of bronchopulmonary dysplasia in preterm infants: a randomized, double-blind, placebo controlled trial. Pediatr Pulmonol. 2011 Feb;46(2):111-8. doi: 10.1002/ppul.21352. Epub 2010 Oct 20.

    PMID: 20963840DERIVED

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature BirthRespiratory Distress Syndrome

Interventions

AzithromycinControl Groups

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Limitations and Caveats

The number of participants for this study was quite small. A large scale trial is required to draw any conclusions.

Results Point of Contact

Title
Dr. Hubert O. Ballard
Organization
University of Kentucky Medical Center
hoball2@uky.edu
859-323-1496

Study Officials

  • Hubert O Ballard, MD

    University of Kentucky

    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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

September 1, 2004

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 27, 2018

Results First Posted

June 27, 2018

Record last verified: 2018-06

Locations

US(1)