Orofacial Difficulties in NewbornsAMACNCT01051843
Orofacial Difficulties in Rooming-in
An observational study of Orofacial Difficulties in Newborns and Maternal Breastfeeding in Newborns, run by Fortaleza University.
Trial summary
The purpose of this study is to identify the orofacial difficulties during the maternal breastfeeding in rooming-in. Read more about this study
- Who is it for?
- Ages 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Orofacial Difficulties in Newborns, Maternal Breastfeeding in Newborns, Newborns in Rooming-in
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 2009
- 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 1 day to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Study population: Cross-sectional study of 29 dyads in rooming-in. The data collection consisted in the detection of the main orofacial difficulties during the maternal breastfeeding in rooming-in.
Who may be able to join
- mothers of the newborns participating in the study, regardless of the gender, ethnic and/or age.
Who cannot join
- newborns who presented oropharyngelarynx structural abnormality, impossibility to feed by mouth and/or exposed in bilispot.
About this study
Official title: Orofacial Difficulties During the Maternal Breastfeeding in Rooming-in
The purpose of this study is to identify the orofacial difficulties during the maternal breastfeeding in rooming-in.
Read the detailed description
Cross-sectional and quantitative study with sample consisted of 28 dyad present in rooming-in of the Assis Chateaubriand School Motherhood during August and December of 2009.
- Conditions
- Orofacial Difficulties in Newborns, Maternal Breastfeeding in Newborns, Newborns in Rooming-in
- Keywords
- Maternal Breastfeeding, Orofacial Difficulties, Rooming-in, Speech and Language Therapy
- Medical subject headings
- Communication Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial Difficulties in 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051843
- Sponsor's protocol ID
- AMAC
- Acronym
- AMAC
- Status last verified
- Aug 2009
- First submitted
- 19 Jan 2010
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orofacial Difficulties During the Maternal Breastfeeding in Rooming-in
- ClinicalTrials.gov ID
- NCT01051843
- Acronym / sponsor ID
- AMAC / AMAC
- Conditions
- Orofacial Difficulties in Newborns, Maternal Breastfeeding in Newborns, Newborns in Rooming-in
- Keywords
- Maternal Breastfeeding, Orofacial Difficulties, Rooming-in, Speech and Language Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Jan 2010 (estimated)
- 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 purpose of this study is to identify the orofacial difficulties during the maternal breastfeeding in rooming-in.
Detailed description
Cross-sectional and quantitative study with sample consisted of 28 dyad present in rooming-in of the Assis Chateaubriand School Motherhood during August and December of 2009.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Cross-sectional study of 29 dyads in rooming-in. The data collection consisted in the detection of the main orofacial difficulties during the maternal breastfeeding in rooming-in.
Key inclusion criteria (1 listed)
- mothers of the newborns participating in the study, regardless of the gender, ethnic and/or age.
Key exclusion criteria (1 listed)
- newborns who presented oropharyngelarynx structural abnormality, impossibility to feed by mouth and/or exposed in bilispot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Jan 2010.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Orofacial Difficulties in Newborns and Maternal Breastfeeding in Newborns, run by Fortaleza University.
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 1 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: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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 20 Jan 2010.