Motor Skills DisordersNCT01660178
Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit
An observational study of Motor Skills Disorders, run by Universidade Federal do Rio de Janeiro.
Trial summary
To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Motor Skills Disorders
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: newborns underwent early stimulation in a neonatal ICU
Who may be able to join
- All cases of newborns who were admitted to the NICU and were referred for treatment of early stimulation
Who cannot join
- all records relating to incomplete study variables and newborns who had a congenital malformation.
About this study
Official title: Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit.
To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation.
Read the detailed description
Objective: To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation.
Methods: It was conducted a descriptive, cross-sectional and analytical study carried out in the General Hospital Dr. Cesar calls, from July to December 2010. The sample consisted of 116 medical records of newborns indicated for the treatment of early stimulation, representing (9.2%). The study excluded seven infants who had some type of congenital malformation. It was used the following variables: weight, sex, gestational age, Apgar score, diagnosis of Respiratory Distress Syndrome and Intracranial Hemorrhage and the use of mechanical ventilation and CPAP.
- Conditions
- Motor Skills Disorders
- Keywords
- newborns, intensive care unit, early stimulation
- Medical subject headings
- Motor Skills Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Skills DisordersStudies 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
- Retrospective
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, karla camila lima de souza, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660178
- Sponsor's protocol ID
- FDAAA
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT01660178
- Acronym / sponsor ID
- FDAAA
- Conditions
- Motor Skills Disorders
- Keywords
- newborns, intensive care unit, early stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Jan 2011
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Aug 2012 (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.
To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation.
Detailed description
Objective: To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation.
Methods: It was conducted a descriptive, cross-sectional and analytical study carried out in the General Hospital Dr. Cesar calls, from July to December 2010. The sample consisted of 116 medical records of newborns indicated for the treatment of early stimulation, representing (9.2%). The study excluded seven infants who had some type of congenital malformation. It was used the following variables: weight, sex, gestational age, Apgar score, diagnosis of Respiratory Distress Syndrome and Intracranial Hemorrhage and the use of mechanical ventilation and CPAP.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- newborns underwent early stimulation in a neonatal ICU
Key inclusion criteria (1 listed)
- All cases of newborns who were admitted to the NICU and were referred for treatment of early stimulation
Key exclusion criteria (1 listed)
- all records relating to incomplete study variables and newborns who had a congenital malformation.
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 8 Aug 2012.
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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 Motor Skills Disorders, run by Universidade Federal do Rio de Janeiro.
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 8 Aug 2012. 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 8 Aug 2012.