Ophthalmia NeonatorumCRY-NOTNCT03528915
Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates
An observational study of Ophthalmia Neonatorum, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 36 weeks
- Conditions the study is for
- Ophthalmia Neonatorum
- What is being tested?
- Rifamycine treatment and whithout Rifamycine treatment
- How many people
- 881 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2015to 24 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Newborns
Who may be able to join
- Newborns at the University Hospital of Amiens> 36SA,
- Admitted in maternity at the exit of nursery
Who cannot join
- Newborns at the Amiens University Hospital <36SA
- Eye drops for any medical reason within the first day of life.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conjunctivitis Incidence in the Newborn Within the First Week of Life: Impact of the Prophylactic Use of Rifamycine(CRY NOT).
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.
- Conditions
- Ophthalmia Neonatorum
- Being tested
- Rifamycine treatment, whithout Rifamycine treatment
- Keywords
- neonate, infant; eyewash; delivery room; prophylaxis; risk factor's
- Medical subject headings
- Ophthalmia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifamycine treatmentOther
Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room.
whithout Rifamycine treatmentOther
Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis group | Newborns treated with rifamycin eye drops systemically two months before change of practices in delivery room. Receives: 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. Receives: Other: whithout Rifamycine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of conjunctivitis during the first 8 days of life in newborns
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start9 Sep 2015
- Primary completion12 May 2016
- Study completion24 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmia NeonatorumStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 881 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528915
- Sponsor's protocol ID
- RNI2014-34 Dr FONTAINE
- Acronym
- CRY-NOT
- Status last verified
- Jan 2019
- First submitted
- 19 Apr 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conjunctivitis Incidence in the Newborn Within the First Week of Life: Impact of the Prophylactic Use of Rifamycine(CRY NOT).
- ClinicalTrials.gov ID
- NCT03528915
- Acronym / sponsor ID
- CRY-NOT / RNI2014-34 Dr FONTAINE
- Conditions
- Ophthalmia Neonatorum
- Keywords
- neonate, infant; eyewash; delivery room; prophylaxis; risk factor's
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 881 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 24 Jul 2016 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis group | – | Other: Rifamycine treatmentNewborns treated with rifamycin eye drops systemically two months before change of practices in delivery room. |
| no-antibiotic group | – | Other: whithout Rifamycine treatmentNewborns not treated with antibiotic prophylaxis in a systemic way, according to the new french guidelines of January 1st, 2015. |
Who may qualify
- Ages
- 36 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns
Key inclusion criteria (2 listed)
- Newborns at the University Hospital of Amiens> 36SA,
- Admitted in maternity at the exit of nursery
Key exclusion criteria (2 listed)
- Newborns at the Amiens University Hospital <36SA
- Eye drops for any medical reason within the first day of life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifamycine treatmentPhone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room. | Other | Prophylaxis group |
| whithout Rifamycine treatmentPhone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines. | Other | no-antibiotic group |
Primary outcome
Occurrence of conjunctivitis during the first 8 days of life in newborns
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmia Neonatorum, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of conjunctivitis during the first 8 days of life in newborns (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.