Relationship Between Oral Hygiene in Newborns and Candida Spp.

NCT ID: NCT03873753

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Little is known regarding the effectiveness of neonatal oral hygiene and its relationship to colonization by Candida spp. in edentulous oral cavities. Thus, the objective of this study is to evaluate whether the oral hygiene of edentulous infants favors colonization by Candida spp. Newborns with up to 48 hours of life will randomly allocated to two groups. The mothers will instructed to clean the oral cavity with gauze and mineral water three times a day, in the test group, and not to clean, in the control group.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Candidiasis, Oral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral cleaning

The oral cavity will be clean with gauze and mineral water three times a day.

Group Type EXPERIMENTAL

Cleaning

Intervention Type OTHER

Gauze and mineral water

No oral cleaning

The oral cavity will not be cleaned.

Group Type ACTIVE_COMPARATOR

No oral cleaning

Intervention Type OTHER

Absence of cleaning

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cleaning

Gauze and mineral water

Intervention Type OTHER

No oral cleaning

Absence of cleaning

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A signed statement of informed consent
* Newborns up to 48 hours of life
* Exclusive breastfeeding
* Edentulous oral cavity

Exclusion Criteria

* Any feeding other than breastfeeding
* Use of pacifier
* Digit sucking
* Systemic alterations
Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Faculty Sao Leopoldo Mandic Campinas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jose Carlos P Imparato

PhD, Senior Lecturer, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jose Carlos P Imparato, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty Sao Leopoldo Mandic

Campinas, São Paulo, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sandra Regina E. da Silva, PhD

Role: CONTACT

+55 11 945179999

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jose Carlos P Imparato, PhD

Role: primary

+551935183601

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SLM 6

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vitality in Infants Via Azithromycin for Neonates Trial
NCT05763693 NOT_YET_RECRUITING PHASE4