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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528915
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Tracking Information
First Submitted Date April 19, 2018
First Posted Date May 18, 2018
Last Update Posted Date January 23, 2019
Actual Study Start Date September 9, 2015
Actual Primary Completion Date May 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2018)
Occurrence of conjunctivitis during the first 8 days of life in newborns [ Time Frame: 8 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates
Official Title Conjunctivitis Incidence in the Newborn Within the First Week of Life: Impact of the Prophylactic Use of Rifamycine(CRY NOT).
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Newborns
Condition Ophthalmia Neonatorum
Intervention
  • Other: Rifamycine treatment
    Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room.
  • Other: whithout Rifamycine treatment
    Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.
Study Groups/Cohorts
  • Prophylaxis group
    Newborns treated with rifamycin eye drops systemically two months before change of practices in delivery room.
    Intervention: Other: Rifamycine treatment
  • no-antibiotic group
    Newborns not treated with antibiotic prophylaxis in a systemic way, according to the new french guidelines of January 1st, 2015.
    Intervention: Other: whithout Rifamycine treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 17, 2018)
881
Original Actual Enrollment Same as current
Actual Study Completion Date July 24, 2016
Actual Primary Completion Date May 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 36 Weeks to 36 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03528915
Other Study ID Numbers RNI2014-34 Dr FONTAINE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date January 2019