Kangaroo Mother Care MethodNCT03611088
Effect of Kangaroo Position on Electromyographic Activity, Macrocirculation and Microcirculation of Preterm Newborns
A study testing Kangaroo Position. in people with Kangaroo Mother Care Method, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
Trial summary
Growing evidences indicates that the Kangaroo Mother Method is associated with health benefits for the child and her mother. Improvements have been found in physiological parameters of the preterm infants assisted by the method. Read more about this study
- Who is it for?
- Ages 27 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Kangaroo Mother Care Method
- 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
- 16 Jul 2018to 31 Oct 2018
- 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 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm newborns with gestational ages older or equal than 27 and less than 37 completed weeks of gestation (Ballard Method)
- Preterm newborns hospitalized at Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) with a corrected age less than 37 weeks at the moment of the evaluation
- Preterm newborns who were not submitted to the Kangaroo Position previously.
Who cannot join
- Apgar less than 7 in the 5''
- Previous history of intracranial hemorrhage (diagnosed by ultrasonography and recorded in the medical record)
- Previous convulsion history
- Congenital infection
- Infections of the central nervous system (meningitis or encephalitis)
- Malformations in the central nervous system
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- Congenital cardiopaths
- Trauma during delivery
- Gastroesophageal reflux disease
- Phototherapy and anemia
Trial locations and contacts
1 site in 1 country.
About this study
Growing evidences indicates that the Kangaroo Mother Method is associated with health benefits for the child and her mother. Improvements have been found in physiological parameters of the preterm infants assisted by the method. Some of them are the reduction of the heart rate and respiratory, as well as the increase of the body temperature and of the arterial saturation of oxygen. More recently, it has been observed that children submitted to the method present an improvement in muscle tone, by the increase in the electromyographic activity of the biceps brachii and hamstrings. These physiological changes can result in benefits for the child, with a positive influence on their development.
It is well established that the preterm newborn has an important circulatory vulnerability, since the transition from fetal life to extrauterine life is a complex process in which the major changes are concentrated in the cardiovascular system and occur during the first Hours after birth accompanied by important consequences in physiological parameters, such as systemic vascular resistance, heart rate and blood flow in the organs. Therefore, global hemodynamic parameters have been studied in premature infants, especially after some intervention. It is worth noting, however, that these global parameters such as blood pressure, heart rate and arterial oxygen saturation do not reflect the existence of adequate tissue oxygenation, since they are macrocirculatory and non-microcirculatory parameters. In order to obtain reliable signals on tissue oxygenation, it is essential to study the microcirculation.
To further explore the effects that Kangaroo Position promotes on the physiological aspects of the newborn, especially on hemodynamic parameters, we consider it important to study aspects that may, in fact, represent an adequate tissue oxygenation. Therefore, the objective of this study is to evaluate the effect of Kangaroo Position in the electromyographic activity and on hemodynamic parameters, by means of microcirculation/macrocirculation measurements.
- Conditions
- Kangaroo Mother Care Method
- Being tested
- Kangaroo Position.
- Keywords
- Child Development, Kangaroo Mother Care Method, Electromyography, Microcirculation, Premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Position.Other
The kangaroo position - the newborn is positioned in the adult's breasts, face down, should be dressed in light clothes and wrapped in a flexible cloth.
| Study group | Role | What they receive |
|---|---|---|
| Newborns submitted to Kangaroo Position. | Experimental | Not described Receives: Other: Kangaroo Position. |
| Newborns not submitted to Kangaroo Position. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic activity
Represented by the recording of the myoelectric signal captured through the electromyographic analysis, analyzed in Root Mean Square (RMS) and measured in microvolts.
Measured: 1 minute
oxygen artery saturation
Represented by the macrocirculation variables
Measured: 1 minute
heart rate
Represented by the macrocirculation variables
Measured: 1 minute
tissue oxygen saturation
Represented by the microcirculation variables
Measured: 1 minute
oxygenated hemoglobin concentration
Represented by the microcirculation variables
Measured: 1 minute
deoxygenated hemoglobin concentration
Represented by the microcirculation variables
Measured: 1 minute
tissue temperature
Represented by the microcirculation variables
Measured: 1 minute
oxygen flow
Represented by the microcirculation variables
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start16 Jul 2018
- Primary completion1 Sep 2018 (estimated)
- Study completion31 Oct 2018 (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 Kangaroo Mother Care MethodStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Rafael Moura Miranda, Professor Fernando Figueira Integral Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611088
- Sponsor's protocol ID
- 69847917.7.0000.5201
- Status last verified
- Aug 2018
- First submitted
- 16 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miranda RM, Cabral Filho JE, Diniz KT, Clough GF, Alves JGB, Lima GMS, Figueredo NPDS, Franca AA, Luna JTB. Effect of Kangaroo Position on microcirculation of preterm newborns: a controlled randomized clinical trial. J Pediatr (Rio J). 2022 Mar-Apr;98(2):196-203. doi: 10.1016/j.jped.2021.05.012. Epub 2021 Aug 26.
PubMed 34454941
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kangaroo Position on Electromyographic Activity, Macrocirculation and Microcirculation of Preterm Newborns
- ClinicalTrials.gov ID
- NCT03611088
- Acronym / sponsor ID
- 69847917.7.0000.5201
- Conditions
- Kangaroo Mother Care Method
- Keywords
- Child Development, Kangaroo Mother Care Method, Electromyography, Microcirculation, Premature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 2 Aug 2018 (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.
Growing evidences indicates that the Kangaroo Mother Method is associated with health benefits for the child and her mother. Improvements have been found in physiological parameters of the preterm infants assisted by the method. Some of them are the reduction of the heart rate and respiratory, as well as the increase of the body temperature and of the arterial saturation of oxygen. More recently, it has been observed that children submitted to the method present an improvement in muscle tone, by the increase in the electromyographic activity of the biceps brachii and hamstrings. These physiological changes can result in benefits for the child, with a positive influence on their development.
It is well established that the preterm newborn has an important circulatory vulnerability, since the transition from fetal life to extrauterine life is a complex process in which the major changes are concentrated in the cardiovascular system and occur during the first Hours after birth accompanied by important consequences in physiological parameters, such as systemic vascular resistance, heart rate and blood flow in the organs. Therefore, global hemodynamic parameters have been studied in premature infants, especially after some intervention. It is worth noting, however, that these global parameters such as blood pressure, heart rate and arterial oxygen saturation do not reflect the existence of adequate tissue oxygenation, since they are macrocirculatory and non-microcirculatory parameters. In order to obtain reliable signals on tissue oxygenation, it is essential to study the microcirculation.
To further explore the effects that Kangaroo Position promotes on the physiological aspects of the newborn, especially on hemodynamic parameters, we consider it important to study aspects that may, in fact, represent an adequate tissue oxygenation. Therefore, the objective of this study is to evaluate the effect of Kangaroo Position in the electromyographic activity and on hemodynamic parameters, by means of microcirculation/macrocirculation measurements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newborns submitted to Kangaroo Position. | Experimental | Other: Kangaroo Position. |
| Newborns not submitted to Kangaroo Position. | No intervention | – |
Who may qualify
- Ages
- 27 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm newborns with gestational ages older or equal than 27 and less than 37 completed weeks of gestation (Ballard Method)
- Preterm newborns hospitalized at Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) with a corrected age less than 37 weeks at the moment of the evaluation
- Preterm newborns who were not submitted to the Kangaroo Position previously.
Key exclusion criteria (10 listed)
- Apgar less than 7 in the 5''
- Previous history of intracranial hemorrhage (diagnosed by ultrasonography and recorded in the medical record)
- Previous convulsion history
- Congenital infection
- 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.The kangaroo position - the newborn is positioned in the adult's breasts, face down, should be dressed in light clothes and wrapped in a flexible cloth. | Other | Newborns submitted to Kangaroo Position. |
Primary outcome
Electromyographic activity
Time frame: 1 minute
Represented by the recording of the myoelectric signal captured through the electromyographic analysis, analyzed in Root Mean Square (RMS) and measured in microvolts.
oxygen artery saturation
Time frame: 1 minute
Represented by the macrocirculation variables
heart rate
Time frame: 1 minute
Represented by the macrocirculation variables
tissue oxygen saturation
Time frame: 1 minute
Represented by the microcirculation variables
oxygenated hemoglobin concentration
Time frame: 1 minute
Represented by the microcirculation variables
deoxygenated hemoglobin concentration
Time frame: 1 minute
Represented by the microcirculation variables
tissue temperature
Time frame: 1 minute
Represented by the microcirculation variables
oxygen flow
Time frame: 1 minute
Represented by the microcirculation variables
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 34454941Miranda RM, Cabral Filho JE, Diniz KT, Clough GF, Alves JGB, Lima GMS, Figueredo NPDS, Franca AA, Luna JTB. Effect of Kangaroo Position on microcirculation of preterm newborns: a controlled randomized clinical trial. J Pediatr (Rio J). 2022 Mar-Apr;98(2):196-203. doi: 10.1016/j.jped.2021.05.012. Epub 2021 Aug 26.
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Impact of Kangroo on Neonates
Not yet recruiting
EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
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Not yet recruiting
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Recruiting
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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.
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 Kangaroo Mother Care Method, 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 10 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 14 Aug 2018. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic activity (time frame: 1 minute). The study lists 8 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 NCT03611088, 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 14 Aug 2018.