Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants

This study has been completed.
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01326611
First received: March 29, 2011
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight < 1250 g and have ureaplasma urealyticum colonization.


Condition Intervention Phase
Chronic Lung Disease
Drug: Clarithromycin
Drug: Dextrose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges [ Time Frame: 12 days after treatment by clarithromycin ] [ Designated as safety issue: Yes ]
    Efficacy of clarithromycin in eradication of Ureaplasma and incidence of CLD were the major outcomes of the study. Nasopharyngeal swabs for Ureaplasma were taken in postnatal first 3 days and on the 12th day only in culture positive infants, transported to the laboratory and cultured for Uu immediately.


Secondary Outcome Measures:
  • To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization. [ Time Frame: From first day of inclusion of study to at postpartum 36th week of day ] [ Designated as safety issue: Yes ]
    Efficacy of clarithromycin in eradication of Ureaplasma urealyticum and incidence of chronic lung disease were the major outcomes of the study. Chronic lung disease of newborn was defined as a persistent oxygen requirement at 36 weeks post menstrual age or death.


Enrollment: 273
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clarithromycine Group: Active Comparator
Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)
Drug: Clarithromycin
Placebo Comparator: Placebo Group: Placebo Comparator
Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.
Drug: Dextrose

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The babies under 1250 gram
  • The babies must be appropriate for gestational age

Exclusion Criteria:

  • Multiple congenital anomalies or known syndromes
  • Intrauterine growth retardation with birthweight less than 10 percentile for gestational age
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326611

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Neonatology department
Ankara, Turkey, 06600
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Study Director: Omer Erdeve, Ass Prof Zekai Tahir Burak Women's Health Research and Education Hospital
Principal Investigator: Evrim Alyamac Dizdar, MD Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01326611     History of Changes
Other Study ID Numbers: rö05053781128
Study First Received: March 29, 2011
Last Updated: March 29, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
Chronic lung disease
Clarithromycin
Ureaplasma urealyticum

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014