Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates

Ophthalmia Neonatorum Clinical Trial

— CRY-NOT  

Official title:

Conjunctivitis Incidence in the Newborn Within the First Week of Life: Impact of the Prophylactic Use of Rifamycine(CRY NOT).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528915
• Other study ID #: RNI2014-34 Dr FONTAINE
• Status: Completed
• Start date: September 9, 2015
• Est. completion date: July 24, 2016

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 881
• Est. completion date: July 24, 2016
• Est. primary completion date: May 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

• Newborns at the University Hospital of Amiens> 36SA,

• Admitted in maternity at the exit of nursery

Exclusion Criteria:

• Newborns at the Amiens University Hospital <36SA

• Eye drops for any medical reason within the first day of life.

Related Conditions & MeSH terms

• Conjunctivitis
• Ophthalmia Neonatorum

Intervention

Other:
• Rifamycine treatment
Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room.
• whithout Rifamycine treatment
Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of conjunctivitis during the first 8 days of life in newborns		8 days