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OpenTrials
Completed

NCT Number: NCT03528915

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

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.

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Key information

Conditions

Ophthalmia Neonatorum Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Eye Diseases Eye Infections Eye Infections, Bacterial Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infections Neisseriaceae Infections

Age range

36 week–36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens-Picardie

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rifamycine treatment

Other

Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room.

whithout Rifamycine treatment

Other

Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.

Primary outcomes

  1. Occurrence of conjunctivitis during the first 8 days of life in newborns

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: CRY-NOT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 18, 2018
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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