Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000120
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Clinical Trial of Eye Prophylaxis in the Newborn
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
To compare side effects of the two prophylactic agents
Detailed Description:
Sexually transmitted diseases are a major cause of neonatal eye infections All 50 States require some eye treatment at birth to prevent gonorrheal eye infections Approximately 3 to 4 million Americans acquire a genital chlamydial infection each year and more than 150000 infants are born to mothers with chlamydial infections These infants are at high risk of developing conjunctivitis and pneumonia
In the State of Washington one of three treatments is presently required by law to help prevent gonorrheal eye infection in newborn babies 1 percent silver nitrate drops erythromycin ointment or tetracycline ointment Although all three treatments appear to prevent eye infections from gonorrhea silver nitrate and erythromycin may also partially prevent chlamydial conjunctivitis However silver nitrate may irritate and damage the eyes of newborns
If it is not known whether the mother is infected it may be better not to give the drugs routinely It could not be clearly established from the medical literature whether the risk to infants from no treatment was higher or lower than the risk from receiving a prophylactic agent Many parents at low risk for gonorrhea prefer that no prophylaxis be given to their newborns Moreover Great Britain which used no eye prophylactic agents for newborns for the 25 years preceding the study has rates of neonatal conjunctivitis similar to those in the United States For these reasons the Washington State Board of Health granted this study an exemption from the State law to allow the investigators to evaluate scientifically the risks and benefits of no treatment
The study was a randomized double-masked clinical trials planned to include 1200 infants born over 3 years The trial compared the efficacy of two treatment regimens silver nitrate and erythromycin in two treatment groups to the outcomes in a control group receiving no prophylaxis Erythromycin was chosen over tetracycline as the antibiotic in this study because it is more commonly used in the United States for ocular prophylaxis
Women were recruited from the University of Washington Medical Center-associated obstetric units Among the 2577 women eligible for possible participation 758 enrolled Of these participants 89 were not randomized Among the 669 randomized women 39 were not available for personal observation These 39 were equally distributed among the three prophylaxis groups In the final participant group the infants of 630 women were evaluable
The infants were randomly assigned to one of these three groups in the delivery room Infants without conjunctivitis were monitored for 2 months after delivery Infants who developed conjunctivitis were monitored for 2 months after successful treatment of their infection The study included extensive efforts to determine the etiology of the conjunctivitis and to find nasolacrimal duct obstruction
In the State of Washington one of three treatments is presently required by law to help prevent gonorrheal eye infection in newborn babies 1 percent silver nitrate drops erythromycin ointment or tetracycline ointment Although all three treatments appear to prevent eye infections from gonorrhea silver nitrate and erythromycin may also partially prevent chlamydial conjunctivitis However silver nitrate may irritate and damage the eyes of newborns
If it is not known whether the mother is infected it may be better not to give the drugs routinely It could not be clearly established from the medical literature whether the risk to infants from no treatment was higher or lower than the risk from receiving a prophylactic agent Many parents at low risk for gonorrhea prefer that no prophylaxis be given to their newborns Moreover Great Britain which used no eye prophylactic agents for newborns for the 25 years preceding the study has rates of neonatal conjunctivitis similar to those in the United States For these reasons the Washington State Board of Health granted this study an exemption from the State law to allow the investigators to evaluate scientifically the risks and benefits of no treatment
The study was a randomized double-masked clinical trials planned to include 1200 infants born over 3 years The trial compared the efficacy of two treatment regimens silver nitrate and erythromycin in two treatment groups to the outcomes in a control group receiving no prophylaxis Erythromycin was chosen over tetracycline as the antibiotic in this study because it is more commonly used in the United States for ocular prophylaxis
Women were recruited from the University of Washington Medical Center-associated obstetric units Among the 2577 women eligible for possible participation 758 enrolled Of these participants 89 were not randomized Among the 669 randomized women 39 were not available for personal observation These 39 were equally distributed among the three prophylaxis groups In the final participant group the infants of 630 women were evaluable
The infants were randomly assigned to one of these three groups in the delivery room Infants without conjunctivitis were monitored for 2 months after delivery Infants who developed conjunctivitis were monitored for 2 months after successful treatment of their infection The study included extensive efforts to determine the etiology of the conjunctivitis and to find nasolacrimal duct obstruction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None