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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. Identifier: NCT03528915
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : January 23, 2019
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment
Ophthalmia Neonatorum Other: Rifamycine treatment Other: whithout Rifamycine treatment

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Study Type : Observational
Actual Enrollment : 881 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Conjunctivitis Incidence in the Newborn Within the First Week of Life: Impact of the Prophylactic Use of Rifamycine(CRY NOT).
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : May 12, 2016
Actual Study Completion Date : July 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
Drug Information available for: Rifamycin

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.

Primary Outcome Measures :
  1. Occurrence of conjunctivitis during the first 8 days of life in newborns [ Time Frame: 8 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03528915

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CHU Amiens-Picardie
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT03528915    
Other Study ID Numbers: RNI2014-34 Dr FONTAINE
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
neonate, infant; eyewash; delivery room; prophylaxis; risk factor's
Additional relevant MeSH terms:
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Ophthalmia Neonatorum
Conjunctival Diseases
Eye Diseases
Eye Infections
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Infant, Newborn, Diseases
Rifamycin SV
Anti-Bacterial Agents
Anti-Infective Agents
Antirheumatic Agents