Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates
CRY-NOT
Conjunctivitis Incidence in the Newborn Within the First Week of Life: Impact of the Prophylactic Use of Rifamycine(CRY NOT).
1 other identifier
observational
881
1 country
1
Brief Summary
The French guidelines for the use of Rifamycine eye drops in delivery room to prevent neonatal conjunctivitis have been actualized. Only newborns exposed to risk factors of conjunctivitis should be treated, compared to previous guidelines, treating all newborns. currently, there are no data describing risk factors for neonatal conjunctivitis. This study evaluated the incidence of conjunctivitis with or without Rifamycine eye drops treatment in the delivery room. Then risk factors for neonatal conjunctivitis where analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2016
CompletedFirst Submitted
Initial submission to the registry
April 19, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedJanuary 23, 2019
January 1, 2019
8 months
April 19, 2018
January 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of conjunctivitis during the first 8 days of life in newborns
8 days
Study Arms (2)
Prophylaxis group
Newborns treated with rifamycin eye drops systemically two months before change of practices in delivery room.
no-antibiotic group
Newborns not treated with antibiotic prophylaxis in a systemic way, according to the new french guidelines of January 1st, 2015.
Interventions
Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room.
Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.
Eligibility Criteria
Newborns
You may qualify if:
- Newborns at the University Hospital of Amiens\> 36SA,
- Admitted in maternity at the exit of nursery
You may not qualify if:
- Newborns at the Amiens University Hospital \<36SA
- Eye drops for any medical reason within the first day of life.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens-Picardie
Amiens, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2018
First Posted
May 18, 2018
Study Start
September 9, 2015
Primary Completion
May 12, 2016
Study Completion
July 24, 2016
Last Updated
January 23, 2019
Record last verified: 2019-01