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Completed

NCT Number: NCT01326611

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

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.

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Key information

Conditions

Chronic Lung Disease

Age range

1 hour–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zekai Tahir Burak Maternity Teaching Hospital Neonatology department

Ankara, 06600, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clarithromycin

Drug

Dextrose

Drug

Primary outcomes

  1. To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges

    Time frame: 12 days after treatment by clarithromycin

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 31, 2011
Registry last updated
Mar 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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