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

C

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

Ophthalmia Neonatorum

Treatments

Other: whithout Rifamycine treatment
Other: Rifamycine treatment

Study type

Observational

Funder types

Other

Identifiers

NCT03528915
RNI2014-34 Dr FONTAINE

Details and patient eligibility

About

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.

Enrollment

881 patients

Sex

All

Ages

36 to 36 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

881 participants in 2 patient groups

Prophylaxis group
Description:
Newborns treated with rifamycin eye drops systemically two months before change of practices in delivery room.
Treatment:
Other: Rifamycine treatment
no-antibiotic group
Description:
Newborns not treated with antibiotic prophylaxis in a systemic way, according to the new french guidelines of January 1st, 2015.
Treatment:
Other: whithout Rifamycine treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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