Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis (Claprum)

This study is currently recruiting participants.
Verified July 2012 by Zekai Tahir Burak Maternity and Teaching Hospital
Sponsor:
Information provided by (Responsible Party):
Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01652118
First received: July 22, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
Drug: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • Bronchopulmonary dysplasia [ Time Frame: 28. day of birth ] [ Designated as safety issue: Yes ]
    On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks ] [ Designated as safety issue: Yes ]
    During to hospitalisation the investigator will determine and record some co-morbidities of BPD such as intracranial hemorrhage, necrotizing enterocolitis, patent ductus arteriosus rates.From date of randomization until the end of the hospitalisation up to the 3 months of life.


Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clarithromycin
Fist group treated with clarithromycin which is include 10 days application.
Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
Other Name: Claprum
Placebo Comparator: placebo
Second group treated with salin as same as amount of clarithromycine volume
Drug: Saline
Other Name: saline

Detailed Description:

The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight.

The investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.

  Eligibility

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

Inclusion Criteria:

  • all infant must be under 1250 gram birth weight

Exclusion Criteria:

  • Major congenital anomaly,
  • CardiaC abnormality,
  • without inform consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652118

Contacts
Contact: Sadık Yurttutan, M.D 0905059079727 sdkyurttutan@gmail.com
Contact: Fuat Emre Canpolat, M.D. femrecan@gmail.com

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Middle Anatolia, Turkey, 06600
Contact: Sadık Yurttutan, M.D    0905059079727      
Contact: Fuat Emre Canpolat, M.D.       femrecan@gmail.com   
Principal Investigator: Sadık Yurttutan, M.D.         
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
Investigators
Study Director: Ugur Dilmen, Prof. Dr. Zekai Tahir Burak Maternity and Teaching Hospital
  More Information

No publications provided

Responsible Party: Sadik Yurttutan, Fellowship of neonatology, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01652118     History of Changes
Other Study ID Numbers: 05059079727
Study First Received: July 22, 2012
Last Updated: July 26, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
bronchopulmonary dysplasia
clarithromycin
preterm babies

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014