Overview

Clinical Trial of Eye Prophylaxis in the Newborn

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye infections. To compare side effects of the two prophylactic agents.
Phase:
Phase 3
Details
Lead Sponsor:
National Eye Institute (NEI)
Treatments:
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Silver Nitrate
Criteria
The study included male and female infants delivered at University Hospital in Seattle,
Washington. Women were recruited after the 28th week of pregnancy and had to be
English-speaking. In addition, they planned to stay at the hospital at least 48 hours
following delivery and lived in the greater Seattle metropolitan area. Infants were
eligible whether they were delivered vaginally or by cesarean section. Excluded from the
study were siblings of infants enrolled in the study, women who were culture-positive for
gonorrhea, infants receiving systemic antimicrobials for reasons other than conjunctivitis,
women receiving antimicrobials at the time of delivery, and families unlikely to be
available for followup after delivery.