NewbornsNCT04410250
Effect of Oral Hygienization in Newborn on Candida Spp Colonization
A study testing oral hygiene in people with Newborns and Oral Hygiene, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
Oral hygiene is one of the most accessible and well-known strategies for the prevention of dental caries. The benefits of this practice after tooth eruption are well established in the literature. Read more about this study
- Who is it for?
- Ages 1 day to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Newborns, Oral Hygiene, Candidiasis, Oral
- What is being tested?
- oral hygiene
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2019to 10 Dec 2020
- Phase
- Interventional
- 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 1 day to 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns who do not yet have erupted teeth at the time of the first assessment (1 month after birth).
- Newborns whose mothers agree with their participation and that of their child in the study.
Who cannot join
- Newborns who present with systemic impairment at the time of the first evaluation (1 month after birth), such as physical, neurological, respiratory diseases, gastroesophageal reflux disease, among others that may alter the oral microbiota.
Trial locations and contacts
1 site in 1 country.
Marcos L Pinheiro, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Ana Beatriz Silva Lopes
Diamantina, Minas Gerais, 39100.000
Ana Beatriz Lopes, 38997493916
About this study
Official title: Effect of Oral Hygienization in Newborn on Candida Spp Colonization and Child Behavior During Hygiene Habits
Oral hygiene is one of the most accessible and well-known strategies for the prevention of dental caries. The benefits of this practice after tooth eruption are well established in the literature. Oral hygiene in newborns prior to tooth eruption is controversial, since there is a disagreement between the Dental and Pediatric Associations as to the optimal time to initiate oral hygiene in children and scientific studies in this regard have not yet been performed. Some of these associations recommend starting this practice from the eruption of the child's first tooth. Others recommend beginning the cleansing of the child's oral cavity from birth by cleaning the baby's gingival rollers and tongue. The aim of the present investigation will be to evaluate, through a randomized clinical trial, the influence of oral hygiene in newborns on Candida spp colonization. and on the child's behavior during oral hygiene after tooth eruption. Will be included in the study, pairs of mothers and babies born in the maternity of the Hospital Nossa Senhora da Saúde, in Diamantina, Minas Gerais, Brazil.
This will be a rehearsal Randomized clinical trial in which newborns will be allocated into 2 groups, namely:
Read more
- Newborns whose parents will receive guidelines for oral hygiene before tooth eruption (Group 1);
- Newborns whose parents will receive instructions not to perform oral hygiene before tooth eruption (Group 2).
The initial data collection will be performed one month after the child's birth and will include oral clinical examinations, saliva collection and questionnaires on the socio-environmental, economic and behavioral aspects of the child and his family. Initial oral clinical examinations will be performed to assess the presence of Candidiasis, and saliva collection will be performed to identify and quantification of Candida spp. These evaluations will be performed again every three months. From the eruption of the first deciduous tooth, the follow-up included an assessment of the baby's behavior during oral hygiene performed by the responsible. This evaluation will be made by the examiner using the Frankl scale and HBCD scale criteria. Statistical analysis will be performed using the Statistical Package for Social Science, version 23.0 and will include descriptive, bivariate and multivariate analyzes.
Read the detailed description
Project presentation:
Primary Objective:
To evaluate the influence of oral hygiene of newborns before dental eruption on colonization by Candida spp. and about the baby's behavior during oral hygiene performed by parents after tooth eruption.
Secondary Objective:
To evaluate the influence of oral hygiene of newborns before tooth eruption on Candida spp colonization and occurrence of candidiasis during the follow-up period. To evaluate the influence of oral hygiene of newborns before tooth eruption on the its behavior during oral hygiene performed by parents after tooth eruption.
Proposed Methodology:
Study design: Randomized blinded clinical trial in edentulous newborns who will be screened in their first two days of life at the Maternity Hospital of Our Lady of Health in Diamantina, Minas Gerais. If mothers agree to participate with their child in the study, contact and address will be requested for further data collection that will be performed at the participants' homes.
Intervention Groups:
- 1. Mothers will be instructed to sanitize the newborn's oral cavity prior to tooth eruption by massaging the gingival rods with gauze and filtered water once a day at night. Following the eruption of the child's first tooth, mothers will be instructed to brush twice daily with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique .
- 2. Mothers will be advised not to perform any type of oral cavity cleaning of the newborn before tooth eruption. Following the eruption of the child's first tooth, mothers will be instructed to brush twice daily with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique .
The calculation of the sample size was obtained from Lee, Laboratory of Epidemiology and Statistics, using the calculation of estimation of two proportions and adopting the parameters proportion of cases (positive behavior during hygiene according to the Frankl Scale) among the exposed (children receiving oral hygiene before tooth eruption): 65% (unpublished data from a previous study by the research group); Confidence level (1 -) = 95%; (= 0.05 or 5%); Test power (1-) = 80%; Relative risk: 1.5; Newborns by group: 42; 9 newborns (20%) will be added to each group to compensate for possible losses. Thus, the sample required for the development of the study will be 51 newborns and their mothers in each of the groups.
The work team will be composed by the Researcher 1, Examiner 1 and Assistants. Prior to the start of the study, these researchers will undergo a training and calibration process according to the role of each team. A pilot study will be performed on 10% of the sample, and if no methodological changes are required, these children will be included in the main study. Randomization will be performed by allocating participants in both intervention groups through a computer-generated random number. Examiner 1 will be blind to the group in which the examined children were allocated and the mothers will be advised not to disclose the group in which they were allocated.
Data Collection and Follow-up Instruments:
Social, Environmental, Behavioral and Health Data Form general of children.
Registration form for colonization evaluation of Candida spp.
Through the identification and quantification of Candida spp. using CHROMagar Candida culture medium. This evaluation will be performed in the first month and at 4 months after the birth of the child. Form for registration of the child's oral clinical examination to record the presence and / or absence of Oral Candidiasis, and if present, its location. After the eruption of the first tooth the examiner will classify the child's behavior according to the Frankl Scale and HBCD Scale using the child's behavior record form that will be used for the period. follow-up at 1 month, 4 months, 7 months, 10 months and 13 months. The child's diet will be assessed through eating habits at all follow-up times through 24-hour dietary reminders using the multi-pass method.
Risks:
The risks inherent to the study are related to the awkwardness of the guardian during the clinical evaluations and / or examinations in the babies, as well as the possible discomfort of the child during the oral clinical examination. However, examiners will be prepared to identify any possible discomfort and minimize or disrupt the assessment if necessary. The application of questionnaires to those responsible will be performed in the presence of the same, in order to reduce their embarrassment. The information collected will be accessible only by members of research.
Benefits:
The benefits to patients will be oral health guidelines, follow-up of children by the examiner and, if necessary, referral for dental treatment. For health professionals, the research will provide scientific evidence and support for guidance to the population that will benefit from such recommendations with better care for children's oral health and consequent improved oral health-related quality of life.
- Conditions
- Newborns, Oral Hygiene, Candidiasis, Oral, Behavior
- Being tested
- oral hygiene
- Keywords
- Neonate., Newborn., Oral hygiene., Oral health., Candidiasis.
- Medical subject headings
- Candidiasis, Oral, Behavior, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral hygieneBehavioural
Mothers will be instructed on the oral hygiene of the newborn
| Study group | Role | What they receive |
|---|---|---|
| Oral hygiene before tooth eruption | Active comparator | The mothers of the newborns allocated to Group 1 will be instructed to clean the child's oral cavity by massaging the gingival rods with gauze and filtered water once a day at night.
Following the eruption of the child's first tooth, mothers will be instructed to brush twice a day with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique. circular movements in the buccal and lingual faces of all teeth (FONES, 1934). Receives: Behavioral: oral hygiene |
| Absence of oral hygiene before tooth eruption | Experimental | The mothers of the newborns allocated to Group 2 will be advised not to perform any type of oral cavity cleaning of the newborn.
Following the eruption of the child's first tooth, mothers will be instructed to brush twice a day with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique. circular movements in the buccal and lingual faces of all teeth (FONES, 1934). Receives: Behavioral: oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization of Candida spp.
In the first month after the birth of the child, an initial oral clinical examination and saliva collection will be performed to evaluate Candida spp colonization. These two assessments will be performed at the child's own home.
Measured: First month after the birth of the child
Colonization of Candida spp.
Four months after the birth of the child, an initial oral clinical examination and saliva collection will be performed to evaluate Candida spp colonization. These two assessments will be performed at the child's own home.
Measured: Four months after the birth of the child
Secondary outcomes (6)
Baby Behavior During Oral Hygiene
The examiner will rate their behavior according to the Frankl Scale. To assess the Frankl scale or the examiner used to classify the behavior of four behavioral categories: (1) definitely positive; (2) positive; (3) negative; (4) definitely negative.
Measured: Seven months after the birth of the child
Baby Behavior During Oral Hygiene
The examiner will rate their behavior according to the HBCD Scale. For an assessment of behavior, an amendment to the HBCD Code , will also be used, with the following definitions: H - A child makes some movement of the head, hindering responsible execution, except movements muscle facial or jaw movements. B - A child moves some part of the body, tries to interrupt the procedure, except when requested by the guardian. C - The child cries, complains or recovering from the procedures. D - The child's behavior interrupts responsible action, causing a delay in the procedure for at least 5 continuous seconds. To be considered non-collaborative, the child must have at least one of the above changes.
Measured: Seven months after the birth of the child
Baby Behavior During Oral Hygiene
The examiner will rate their behavior according to the Frankl Scale. To assess the Frankl scale or the examiner used to classify the behavior of four behavioral categories: (1) definitely positive; (2) positive; (3) negative; (4) definitely negative.
Measured: Ten months after the birth of the child
Baby Behavior During Oral Hygiene
The examiner will rate their behavior according to the HBCD Scale. For an assessment of behavior, an amendment to the HBCD Code , will also be used, with the following definitions: H - A child makes some movement of the head, hindering responsible execution, except movements muscle facial or jaw movements. B - A child moves some part of the body, tries to interrupt the procedure, except when requested by the guardian. C - The child cries, complains or recovering from the procedures. D - The child's behavior interrupts responsible action, causing a delay in the procedure for at least 5 continuous seconds. To be considered non-collaborative, the child must have at least one of the above changes.
Measured: Ten months after the birth of the child
Baby Behavior During Oral Hygiene
The examiner will rate their behavior according to the HBCD Scale. For an assessment of behavior, an amendment to the HBCD Code , will also be used, with the following definitions: H - A child makes some movement of the head, hindering responsible execution, except movements muscle facial or jaw movements. B - A child moves some part of the body, tries to interrupt the procedure, except when requested by the guardian. C - The child cries, complains or recovering from the procedures. D - The child's behavior interrupts responsible action, causing a delay in the procedure for at least 5 continuous seconds. To be considered non-collaborative, the child must have at least one of the above changes.
Measured: Thirteen months after the birth of the child
Baby Behavior During Oral Hygiene
The examiner will rate their behavior according to the Frankl Scale. To assess the Frankl scale or the examiner used to classify the behavior of four behavioral categories: (1) definitely positive; (2) positive; (3) negative; (4) definitely negative.
Measured: Thirteen months after the birth of the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Nov 2019
- Primary completion6 Aug 2020 (estimated)
- Study completion10 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sample Size in Brazil: 102 Groups into which survey participants will be divided at this center: Group 1: 51 (Newborns whose parents will receive oral hygiene guidelines prior to tooth eruption) Group 2: 51 ( Newborns whose parents will be advised not to perform oral hygiene prior to tooth eruption.)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Beatriz S Lopes, Graduated, Principal investigator, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410250
- Sponsor's protocol ID
- 3.568.480
- Status last verified
- May 2020
- First submitted
- 23 Sep 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Hygienization in Newborn on Candida Spp Colonization and Child Behavior During Hygiene Habits
- ClinicalTrials.gov ID
- NCT04410250
- Acronym / sponsor ID
- 3.568.480
- Conditions
- Newborns, Oral Hygiene, Candidiasis, Oral, Behavior
- Keywords
- Neonate., Newborn., Oral hygiene., Oral health., Candidiasis.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 6 Aug 2020 (estimated)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 1 Jun 2020 (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.
Oral hygiene is one of the most accessible and well-known strategies for the prevention of dental caries. The benefits of this practice after tooth eruption are well established in the literature. Oral hygiene in newborns prior to tooth eruption is controversial, since there is a disagreement between the Dental and Pediatric Associations as to the optimal time to initiate oral hygiene in children and scientific studies in this regard have not yet been performed. Some of these associations recommend starting this practice from the eruption of the child's first tooth. Others recommend beginning the cleansing of the child's oral cavity from birth by cleaning the baby's gingival rollers and tongue. The aim of the present investigation will be to evaluate, through a randomized clinical trial, the influence of oral hygiene in newborns on Candida spp colonization. and on the child's behavior during oral hygiene after tooth eruption. Will be included in the study, pairs of mothers and babies born in the maternity of the Hospital Nossa Senhora da Saúde, in Diamantina, Minas Gerais, Brazil.
This will be a rehearsal Randomized clinical trial in which newborns will be allocated into 2 groups, namely:
- Newborns whose parents will receive guidelines for oral hygiene before tooth eruption (Group 1);
- Newborns whose parents will receive instructions not to perform oral hygiene before tooth eruption (Group 2).
The initial data collection will be performed one month after the child's birth and will include oral clinical examinations, saliva collection and questionnaires on the socio-environmental, economic and behavioral aspects of the child and his family. Initial oral clinical examinations will be performed to assess the presence of Candidiasis, and saliva collection will be performed to identify and quantification of Candida spp. These evaluations will be performed again every three months. From the eruption of the first deciduous tooth, the follow-up included an assessment of the baby's behavior during oral hygiene performed by the responsible. This evaluation will be made by the examiner using the Frankl scale and HBCD scale criteria. Statistical analysis will be performed using the Statistical Package for Social Science, version 23.0 and will include descriptive, bivariate and multivariate analyzes.
Detailed description
Project presentation:
Primary Objective:
To evaluate the influence of oral hygiene of newborns before dental eruption on colonization by Candida spp. and about the baby's behavior during oral hygiene performed by parents after tooth eruption.
Secondary Objective:
To evaluate the influence of oral hygiene of newborns before tooth eruption on Candida spp colonization and occurrence of candidiasis during the follow-up period. To evaluate the influence of oral hygiene of newborns before tooth eruption on the its behavior during oral hygiene performed by parents after tooth eruption.
Proposed Methodology:
Study design: Randomized blinded clinical trial in edentulous newborns who will be screened in their first two days of life at the Maternity Hospital of Our Lady of Health in Diamantina, Minas Gerais. If mothers agree to participate with their child in the study, contact and address will be requested for further data collection that will be performed at the participants' homes.
Intervention Groups:
- 1. Mothers will be instructed to sanitize the newborn's oral cavity prior to tooth eruption by massaging the gingival rods with gauze and filtered water once a day at night. Following the eruption of the child's first tooth, mothers will be instructed to brush twice daily with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique .
- 2. Mothers will be advised not to perform any type of oral cavity cleaning of the newborn before tooth eruption. Following the eruption of the child's first tooth, mothers will be instructed to brush twice daily with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique .
The calculation of the sample size was obtained from Lee, Laboratory of Epidemiology and Statistics, using the calculation of estimation of two proportions and adopting the parameters proportion of cases (positive behavior during hygiene according to the Frankl Scale) among the exposed (children receiving oral hygiene before tooth eruption): 65% (unpublished data from a previous study by the research group); Confidence level (1 -) = 95%; (= 0.05 or 5%); Test power (1-) = 80%; Relative risk: 1.5; Newborns by group: 42; 9 newborns (20%) will be added to each group to compensate for possible losses. Thus, the sample required for the development of the study will be 51 newborns and their mothers in each of the groups.
The work team will be composed by the Researcher 1, Examiner 1 and Assistants. Prior to the start of the study, these researchers will undergo a training and calibration process according to the role of each team. A pilot study will be performed on 10% of the sample, and if no methodological changes are required, these children will be included in the main study. Randomization will be performed by allocating participants in both intervention groups through a computer-generated random number. Examiner 1 will be blind to the group in which the examined children were allocated and the mothers will be advised not to disclose the group in which they were allocated.
Data Collection and Follow-up Instruments:
Social, Environmental, Behavioral and Health Data Form general of children.
Registration form for colonization evaluation of Candida spp.
Through the identification and quantification of Candida spp. using CHROMagar Candida culture medium. This evaluation will be performed in the first month and at 4 months after the birth of the child. Form for registration of the child's oral clinical examination to record the presence and / or absence of Oral Candidiasis, and if present, its location. After the eruption of the first tooth the examiner will classify the child's behavior according to the Frankl Scale and HBCD Scale using the child's behavior record form that will be used for the period. follow-up at 1 month, 4 months, 7 months, 10 months and 13 months. The child's diet will be assessed through eating habits at all follow-up times through 24-hour dietary reminders using the multi-pass method.
Risks:
The risks inherent to the study are related to the awkwardness of the guardian during the clinical evaluations and / or examinations in the babies, as well as the possible discomfort of the child during the oral clinical examination. However, examiners will be prepared to identify any possible discomfort and minimize or disrupt the assessment if necessary. The application of questionnaires to those responsible will be performed in the presence of the same, in order to reduce their embarrassment. The information collected will be accessible only by members of research.
Benefits:
The benefits to patients will be oral health guidelines, follow-up of children by the examiner and, if necessary, referral for dental treatment. For health professionals, the research will provide scientific evidence and support for guidance to the population that will benefit from such recommendations with better care for children's oral health and consequent improved oral health-related quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sample Size in Brazil: 102 Groups into which survey participants will be divided at this center: Group 1: 51 (Newborns whose parents will receive oral hygiene guidelines prior to tooth eruption) Group 2: 51 ( Newborns whose parents will be advised not to perform oral hygiene prior to tooth eruption.)
| Arm | Type | Receives |
|---|---|---|
| Oral hygiene before tooth eruption | Active comparator | Behavioral: oral hygieneThe mothers of the newborns allocated to Group 1 will be instructed to clean the child's oral cavity by massaging the gingival rods with gauze and filtered water once a day at night. Following the eruption of the child's first tooth, mothers will be instructed to brush twice a day with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique. circular movements in the buccal and lingual faces of all teeth (FONES, 1934). |
| Absence of oral hygiene before tooth eruption | Experimental | Behavioral: oral hygieneThe mothers of the newborns allocated to Group 2 will be advised not to perform any type of oral cavity cleaning of the newborn. Following the eruption of the child's first tooth, mothers will be instructed to brush twice a day with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique. circular movements in the buccal and lingual faces of all teeth (FONES, 1934). |
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborns who do not yet have erupted teeth at the time of the first assessment (1 month after birth).
- Newborns whose mothers agree with their participation and that of their child in the study.
Key exclusion criteria (1 listed)
- Newborns who present with systemic impairment at the time of the first evaluation (1 month after birth), such as physical, neurological, respiratory diseases, gastroesophageal reflux disease, among others that may alter the oral microbiota.
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 |
|---|---|---|
| oral hygieneMothers will be instructed on the oral hygiene of the newborn | Behavioural | Absence of oral hygiene before tooth eruption, Oral hygiene before tooth eruption |
Primary outcome
Colonization of Candida spp.
Time frame: First month after the birth of the child
In the first month after the birth of the child, an initial oral clinical examination and saliva collection will be performed to evaluate Candida spp colonization. These two assessments will be performed at the child's own home.
Colonization of Candida spp.
Time frame: Four months after the birth of the child
Four months after the birth of the child, an initial oral clinical examination and saliva collection will be performed to evaluate Candida spp colonization. These two assessments will be performed at the child's own home.
6 secondary outcomes
Baby Behavior During Oral Hygiene
Time frame: Seven months after the birth of the child
Baby Behavior During Oral Hygiene
Time frame: Seven months after the birth of the child
Baby Behavior During Oral Hygiene
Time frame: Ten months after the birth of the child
Baby Behavior During Oral Hygiene
Time frame: Ten months after the birth of the child
Baby Behavior During Oral Hygiene
Time frame: Thirteen months after the birth of the child
Baby Behavior During Oral Hygiene
Time frame: Thirteen months after the birth of the child
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Newborns
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
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.
Marcos L Pinheiro, PhD contact
Ana Beatriz S Lopes, Graduated principal investigator
Federal University of the Valleys of Jequitinhonha and Mucuri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral hygiene in people with Newborns and Oral Hygiene, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 2020. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Beatriz S Lopes, Graduated ((38)9 9749-3916, anabeatriz.lopes@hotmail.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonization of Candida spp. (time frame: First month after the birth of the child). The study lists 2 primary outcomes in all. 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 1 Jun 2020.