NCT00000120

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1985

Completed
14.7 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

First QC Date

September 23, 1999

Last Update Submit

September 16, 2009

Conditions

Chlamydia InfectionsOphthalmia Neonatorum

Keywords

Neonatal Conjunctivitis

Interventions

Erythromycin OintmentDRUG
Silver Nitrate DropsDRUG

Eligibility Criteria

AgeUp to 1 Year
Sexall
Age GroupsChild (0-17)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Krohn MA, Hillier SL, Bell TA, Kronmal RA, Grayston JT. The bacterial etiology of conjunctivitis in early infancy. Eye Prophylaxis Study Group. Am J Epidemiol. 1993 Sep 1;138(5):326-32. doi: 10.1093/oxfordjournals.aje.a116862.

    PMID: 8356971BACKGROUND

  • Bell TA, Grayston JT, Krohn MA, Kronmal RA. Randomized trial of silver nitrate, erythromycin, and no eye prophylaxis for the prevention of conjunctivitis among newborns not at risk for gonococcal ophthalmitis. Eye Prophylaxis Study Group. Pediatrics. 1993 Dec;92(6):755-60.

    PMID: 8233733BACKGROUND

MeSH Terms

Conditions

Chlamydia InfectionsOphthalmia Neonatorum

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesConjunctivitis, BacterialEye Infections, BacterialNeisseriaceae InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

January 1, 1985

Last Updated

September 17, 2009

Record last verified: 2009-09