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 ]

  1. respiratory distress syndrome(RDS)
  2. bronchopulmonary dysplasia(BPD)
  3. intraventricular hemorrhage(IVH,≥grade 3)
  4. retinopathy of prematurity(ROP,≥grade 3)
  5. necrotizing enterocolitis(NEC,≥stage 2)
  6. 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 ]

The outcome will be evaluated in five sub-domains (development, neurologic examination, Bayley Scales of Infant Development-II, vision, and hearing). The final outcome scale was divided into normal, mild, moderate, and severe disability


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