Child DevelopmentNCT02849665
Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm
A study testing Kangaroo Position in people with Child Development, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
Trial summary
Introdution: The Kangaroo Mother Care is a perinatal care model for preterm and low weight newborn. The Kangaroo Position is the main feature of this method. The infant should be lightly dressed, in prone position and upright against the torax of the parents. Read more about this study
- Who is it for?
- Ages 27 to 35 weeksHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Kangaroo Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2016to Aug 2017
- 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 27 to 35 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- a gestational age of 27-34 weeks;
- corrected age of until 35 weeks at the time of the first examination;
- had not previously been in the kangaroo position;
Who cannot join
- Apgar lower than 7 in the 5th min;
- a history of grade III or IV intracranial haemorrhage (diagnosed by way of transfontanelar ultrasound and included in the medical records);
- seizures;
- congenital infections (cytomegalovirus, rubella, toxoplasmosis, syphilis and vertically transmitted HIV)
- malformations of the central nervous system (hydrocephaly and genetic syndromes), infections of the central nervous system (meningitis or encephalitis);
- congenital cardiopathy;
- traumas during delivery (injuries to the brachial plexus, dislocation of the hip and pelvis fractures) and gastro-oesophageal reflux disorder.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Unidade Canguru
Recife, Pernambuco, 50070-550
Geisy Maria Souza Lima, MD, 55 81 21224125, canguru@imip.org.br
About this study
Official title: Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm: A Randomized Clinical Trial.
Introdution: The Kangaroo Mother Care is a perinatal care model for preterm and low weight newborn. The Kangaroo Position is the main feature of this method. The infant should be lightly dressed, in prone position and upright against the torax of the parents. Researches provides evidence that the Kangaroo Position induces an increase in myoelectric activity of preterm newborn. However, it is unknown how long the newborn should remain in the kangaroo Position so that ocurr changes in electromyographic. An increase in electromyographic activity was observed after 24 hours or more of submission to the Position Kangaroo, however period lower of submission to the Position Kangaroo have not been evaluated yet. Also unknown are the physiological mechanisms that cause this muscle response. One hypothesis would be the increase in temperature caused by skin to skin contact which could improve circulation in small vessels with direct influence on the infusion and nutrition of muscle tissue. Objective: Evaluate the immediate effect of Kangaroo position in the electromyographic activity and microcirculation of preterm newborn. Method: It will be a randomized and controlled trial from August 2016 to February 2017 with newborn preterm admitted at the Kangaroo Unit, IMIP. Newborns eligible according to the inclusion and exclusion criteria will be randomized into two groups: Kangaroo Group (experimental group) and Not Kangaroo Group (control group). The data of the electromyographic activity and the microcirculatory parameters will be assessed and recorded in three stages: before the Kangaroo position, one and three hours after of continuous submission in the Kangaroo Position (for the group of cases) and before the Kangaroo position, one and four after the three assessments (for the control group). In the control group, the preterm newborns will be not submitted to Kangaroo position until the completion of the last and third evaluation. The acquisition of the electromyographic signal will be conducted through an equipment electromyography Miotool 400® brand (Miotec Equipamentos Biomédicos - Brasil). To assess microcirculation will be used for the white light spectroscopy method through the drive moorVMS-OXY®. The project was submitted and approved by Ethics Committee for Research on Human Beings of IMIP (52381915.5.0000.5201). This study is part of a anchor project approved by Conselho Nacional de Desenvolvimento Científico e Tecnológico- CNPq (process 458163/2014-7).
- Conditions
- Child Development
- Being tested
- Kangaroo Position
- Keywords
- Kangaroo-Mother Care Method; child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo PositionOther
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Position | Experimental | The newborn remains in a vertical position, with limbs flexed, dressed in light clothes, maintaining skin-to-skin contact and the face on the adult's thorax. Receives: Other: Kangaroo Position |
| Not Kangaroo Position | No intervention | The newborns will be not placed in the position Kangaroo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic activity
Measure of the changes in electric potential of muscle.
Measured: 15 minutes
Tissue oxygen saturation - SO2
Measured: 5 minutes
Relative oxygenated haemoglobin concentration - oxyHb
Measured: 5 minutes
Relative deoxygenated haemoglobin concentration - deoxyHb
Measured: 5 minutes
Relative total haemoglobin concentration -totalHb
Measured: 5 minutes
Temperature
Tissue temperature
Measured: 5 minutes
Blood flow
A quantity proportional to the product of the average speed of the blood cells and their number concentration.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start1 Oct 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaísa Trovão Diniz, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- José E. Cabral Filho, PhD, Study director, Instituto de Medicina Integral Prof. Fernando Figueira - IMIPRafael M. Miranda, PhD student, Study chair, Instituto de Medicina Integral Prof. Fernando Figueira - IMIPJoão G. Bezerra alves, PhD, Study chair, Instituto de Medicina Integral Prof. Fernando Figueira - IMIPGeraldine F. Clough, PhD, Study chair, University of Southampton - Academic Unit of Human Development and HealthKaísa T. Diniz, PhD student, Principal investigator, Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849665
- Sponsor's protocol ID
- 458163/2014-7
- Status last verified
- Aug 2017
- First submitted
- 26 Jul 2016
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Diniz KT, Cabral Filho JE, Miranda RM, Lima GMS, Figueredo NPDS, Araujo KFN. Short-time effect of the kangaroo position on electromyographic activity of premature infants: a randomized clinical trial. J Pediatr (Rio J). 2020 Nov-Dec;96(6):741-747. doi: 10.1016/j.jped.2019.10.003. Epub 2019 Oct 14.
PubMed 31622569
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02849665
- Acronym / sponsor ID
- 458163/2014-7
- Conditions
- Child Development
- Keywords
- Kangaroo-Mother Care Method; child development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Study start
- 1 Oct 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 29 Jul 2016 (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.
Introdution: The Kangaroo Mother Care is a perinatal care model for preterm and low weight newborn. The Kangaroo Position is the main feature of this method. The infant should be lightly dressed, in prone position and upright against the torax of the parents. Researches provides evidence that the Kangaroo Position induces an increase in myoelectric activity of preterm newborn. However, it is unknown how long the newborn should remain in the kangaroo Position so that ocurr changes in electromyographic. An increase in electromyographic activity was observed after 24 hours or more of submission to the Position Kangaroo, however period lower of submission to the Position Kangaroo have not been evaluated yet. Also unknown are the physiological mechanisms that cause this muscle response. One hypothesis would be the increase in temperature caused by skin to skin contact which could improve circulation in small vessels with direct influence on the infusion and nutrition of muscle tissue. Objective: Evaluate the immediate effect of Kangaroo position in the electromyographic activity and microcirculation of preterm newborn. Method: It will be a randomized and controlled trial from August 2016 to February 2017 with newborn preterm admitted at the Kangaroo Unit, IMIP. Newborns eligible according to the inclusion and exclusion criteria will be randomized into two groups: Kangaroo Group (experimental group) and Not Kangaroo Group (control group). The data of the electromyographic activity and the microcirculatory parameters will be assessed and recorded in three stages: before the Kangaroo position, one and three hours after of continuous submission in the Kangaroo Position (for the group of cases) and before the Kangaroo position, one and four after the three assessments (for the control group). In the control group, the preterm newborns will be not submitted to Kangaroo position until the completion of the last and third evaluation. The acquisition of the electromyographic signal will be conducted through an equipment electromyography Miotool 400® brand (Miotec Equipamentos Biomédicos - Brasil). To assess microcirculation will be used for the white light spectroscopy method through the drive moorVMS-OXY®. The project was submitted and approved by Ethics Committee for Research on Human Beings of IMIP (52381915.5.0000.5201). This study is part of a anchor project approved by Conselho Nacional de Desenvolvimento Científico e Tecnológico- CNPq (process 458163/2014-7).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Position | Experimental | Other: Kangaroo PositionThe newborn remains in a vertical position, with limbs flexed, dressed in light clothes, maintaining skin-to-skin contact and the face on the adult's thorax. |
| Not Kangaroo Position | No intervention | –The newborns will be not placed in the position Kangaroo. |
Who may qualify
- Ages
- 27 to 35 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a gestational age of 27-34 weeks;
- corrected age of until 35 weeks at the time of the first examination;
- had not previously been in the kangaroo position;
Key exclusion criteria (7 listed)
- Apgar lower than 7 in the 5th min;
- a history of grade III or IV intracranial haemorrhage (diagnosed by way of transfontanelar ultrasound and included in the medical records);
- seizures;
- congenital infections (cytomegalovirus, rubella, toxoplasmosis, syphilis and vertically transmitted HIV)
- malformations of the central nervous system (hydrocephaly and genetic syndromes), infections of the central nervous system (meningitis or encephalitis);
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 |
|---|---|---|
| Kangaroo Position | Other | Kangaroo Position |
Primary outcome
Electromyographic activity
Time frame: 15 minutes
Measure of the changes in electric potential of muscle.
Tissue oxygen saturation - SO2
Time frame: 5 minutes
Relative oxygenated haemoglobin concentration - oxyHb
Time frame: 5 minutes
Relative deoxygenated haemoglobin concentration - deoxyHb
Time frame: 5 minutes
Relative total haemoglobin concentration -totalHb
Time frame: 5 minutes
Temperature
Time frame: 5 minutes
Tissue temperature
Blood flow
Time frame: 5 minutes
A quantity proportional to the product of the average speed of the blood cells and their number concentration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Derived from this study: PubMed 31622569Diniz KT, Cabral Filho JE, Miranda RM, Lima GMS, Figueredo NPDS, Araujo KFN. Short-time effect of the kangaroo position on electromyographic activity of premature infants: a randomized clinical trial. J Pediatr (Rio J). 2020 Nov-Dec;96(6):741-747. doi: 10.1016/j.jped.2019.10.003. Epub 2019 Oct 14.
- Individual participant dataSharing planned: Undecided
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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.
José E. Cabral Filho, PhD study director
Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
Rafael M. Miranda, PhD student study chair
Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
João G. Bezerra alves, PhD study chair
Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Position in people with Child Development, run by Professor Fernando Figueira Integral Medicine Institute 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 3 inclusion and 7 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 16 Aug 2017. 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 Kaísa T. Diniz, PhD student (+55 81 999328432, kaisa.tdz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic activity (time frame: 15 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02849665, which also lists 1 linked publication.
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 16 Aug 2017.