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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Completed
• CT.gov ID: NCT03528915
• Collaborator: (none)
• Enrollment: 881
• Location: 1
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 84.1

Study Details

Study Description

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	Phase
Ophthalmia Neonatorum	Other: Rifamycine treatment; Other: whithout Rifamycine treatment

Study Design

• 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: Sep 9, 2015
• Actual Primary Completion Date: May 12, 2016
• Actual Study Completion Date: Jul 24, 2016

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 36 Weeks to 36 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens-Picardie	Amiens		France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03528915
• Other Study ID Numbers: RNI2014-34 Dr FONTAINE
• First Posted: May 18, 2018
• Last Update Posted: Jan 23, 2019
• Last Verified: Jan 1, 2019

• 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: Ophthalmia Neonatorum; Conjunctivitis; Rifamycins; Rifamycin SV

Study Results

No Results Posted as of Jan 23, 2019