Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates (CRY-NOT)

January 21, 2019 updated by: Centre Hospitalier Universitaire, Amiens

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

881

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prophylaxis group
Newborns treated with rifamycin eye drops systemically two months before change of practices in delivery room.
Other: Rifamycine treatment
Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment 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.
Other: whithout Rifamycine treatment
Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of conjunctivitis during the first 8 days of life in newborns
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2015

Primary Completion (Actual)

May 12, 2016

Study Completion (Actual)

July 24, 2016

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI2014-34 Dr FONTAINE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ophthalmia Neonatorum

Clinical Trials on Rifamycine treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe