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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01326611

Enrollment

273

Registered

2011-03-31

Start date

2008-05-31

Completion date

2010-12-31

Last updated

2011-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lung Disease

Keywords

Chronic lung disease, Clarithromycin, Ureaplasma urealyticum

Brief summary

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.

Interventions

DRUGClarithromycin

DRUGDextrose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Hours to 2 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges	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

Measure	Time frame	Description
To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization.	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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026