Clinical Trial: Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.
Brief Summary: The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.
Detailed Summary:
Sponsor: Samsung Medical Center
Current Primary Outcome: Neonatal composite morbidity [ Time Frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks ]
- respiratory distress syndrome(RDS)
- bronchopulmonary dysplasia(BPD)
- intraventricular hemorrhage(IVH,≥grade 3)
- retinopathy of prematurity(ROP,≥grade 3)
- necrotizing enterocolitis(NEC,≥stage 2)
- proven neonatal sepsis
Original Primary Outcome: Same as current
Current Secondary Outcome: infantile neurologic outcome [ Time Frame: at 6 months and 1 year of corrected age ]
Original Secondary Outcome: Same as current
Information By: Samsung Medical Center
Dates:
Date Received: December 25, 2011
Date Started: October 2011
Date Completion:
Last Updated: November 24, 2015
Last Verified: November 2015