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CompletedNCT03528915CRY-NOTUpdated Jan 23, 2019

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

An observational study in Ophthalmia Neonatorum, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 36 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
881
Ages
36 Weeks to 36 Weeks
Sex
All
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Study 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.

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Conditions studied

  • Ophthalmia Neonatorum

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Keywords

  • neonate, infant; eyewash; delivery room; prophylaxis; risk factor's
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In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 881 is above the median of 152 across 47 observational studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
36 Weeks to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newborns

Inclusion criteria

  • Newborns at the University Hospital of Amiens> 36SA,
  • Admitted in maternity at the exit of nursery

Exclusion criteria

Exclusion Criteria:

  • Newborns at the Amiens University Hospital \<36SA
  • Eye drops for any medical reason within the first day of life.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
881 participants (actual)
Patient registry
No

Groups and cohorts

  • Prophylaxis group

    Newborns treated with rifamycin eye drops systemically two months before change of practices in delivery room.

    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.

    Other: whithout Rifamycine treatment

Interventions

  • OtherRifamycine treatment

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

  • Otherwhithout Rifamycine treatment

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

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What researchers measure

Primary outcomes

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

    Time frame: 8 days

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Study locations

1 site
  • CHU Amiens-Picardie
    Amiens, 80054, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03528915
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
May 18, 2018
Start date
Sep 9, 2015
Primary completion
May 12, 2016
Completion
Jul 24, 2016
Last update
Jan 23, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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