Infant, Premature, DiseasesNCT02668107
Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning
A study testing Hammock positioning in people with Infant, Premature, Diseases, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
To compare and analyze the effects on the electromyographic activity of preterm newborns placed in the hammock position with the activity of newborns not placed in this position. Read more about this study
- Who is it for?
- Ages 1 day to 20 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- Hammock positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Oct 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 1 day to 20 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm Infants with gestational age <34 weeks
- Free from mechanical ventilation in the last 48 hours prior to electromyographic evaluation
- Not in use of supplemental oxygen at the time of assessment
Who cannot join
- Apgar score of less than seven in the fifth minute
- Previous history of perintraventricular hemorrhage grade III and / or IV
- Congenital infection
- Congenital heart defects
- Neonatal Obstetric traumas
- Gastroesophageal Reflux Disease
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- Genetic syndromes
- Congenital malformations
- Sepsis with meningitis
- Orthopedic and musculoskeletal alterations
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-550
About this study
Official title: Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning : a Randomized Clinical Trial
To compare and analyze the effects on the electromyographic activity of preterm newborns placed in the hammock position with the activity of newborns not placed in this position.
Read the detailed description
Randomized clinical trial, according to CONSORT standards, with newborn preterm gestational age <34 weeks and birth weight <1500 g, admitted to the intensive care unit. Newborns will be randomized. Those selected for the control group (CG) will be placed in the incubator following the service routine. Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments. The evaluation of muscle activity will be carried out through surface electromyography. Evaluations shall be performed immediately before the intervention; immediately after 24 hours of intervention; and within 24 hours without intervention, in order to compare the values before and after the intervention of the two groups, as well as if the effects of the intervention are maintained after its removal.
- Conditions
- Infant, Premature, Diseases
- Being tested
- Hammock positioning
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hammock positioningOther
Babies in the intervention group (IG), will be positioned supine in a hammock(hammock positioning) in the incubator, with the appropriate postural adjustments.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Hammock positioning) | Active comparator | Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments. Receives: Other: Hammock positioning |
| Control Group | No intervention | Those selected for the control group (CG) will be placed in the incubator following the service routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Muscle activity
In preterm infants placed in hammocks with gestational age less than or equal to 34 weeks and birth weight less than or equal to 1500g:
- Muscle activity of the elbow flexors (corresponding to the biceps muscle) and knee flexors (corresponding mainly to the hamstring muscle group) increases.
- The increase in electromyographic activity persists 24 hours after removal of the intervention.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Cristina de Almeida Eyre, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Isabel Eyre, Bachelor, Principal investigator, Instituto de Medicina Integral Professor Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668107
- Sponsor's protocol ID
- CAAE 43874915.0.0000.5201
- Status last verified
- Aug 2017
- First submitted
- 26 Jan 2016
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02668107
- Acronym / sponsor ID
- CAAE 43874915.0.0000.5201
- Conditions
- Infant, Premature, Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 29 Jan 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.
To compare and analyze the effects on the electromyographic activity of preterm newborns placed in the hammock position with the activity of newborns not placed in this position.
Detailed description
Randomized clinical trial, according to CONSORT standards, with newborn preterm gestational age <34 weeks and birth weight <1500 g, admitted to the intensive care unit. Newborns will be randomized. Those selected for the control group (CG) will be placed in the incubator following the service routine. Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments. The evaluation of muscle activity will be carried out through surface electromyography. Evaluations shall be performed immediately before the intervention; immediately after 24 hours of intervention; and within 24 hours without intervention, in order to compare the values before and after the intervention of the two groups, as well as if the effects of the intervention are maintained after its removal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Hammock positioning) | Active comparator | Other: Hammock positioningBabies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments. |
| Control Group | No intervention | –Those selected for the control group (CG) will be placed in the incubator following the service routine. |
Who may qualify
- Ages
- 1 day to 20 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm Infants with gestational age <34 weeks
- Free from mechanical ventilation in the last 48 hours prior to electromyographic evaluation
- Not in use of supplemental oxygen at the time of assessment
Key exclusion criteria (10 listed)
- Apgar score of less than seven in the fifth minute
- Previous history of perintraventricular hemorrhage grade III and / or IV
- Congenital infection
- Congenital heart defects
- Neonatal Obstetric traumas
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 |
|---|---|---|
| Hammock positioningBabies in the intervention group (IG), will be positioned supine in a hammock(hammock positioning) in the incubator, with the appropriate postural adjustments. | Other | Intervention Group (Hammock positioning) |
Primary outcome
Increase in Muscle activity
Time frame: 24 hours
In preterm infants placed in hammocks with gestational age less than or equal to 34 weeks and birth weight less than or equal to 1500g: 1. Muscle activity of the elbow flexors (corresponding to the biceps muscle) and knee flexors (corresponding mainly to the hamstring muscle group) increases. 2. The increase in electromyographic activity persists 24 hours after removal of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Isabel Eyre, Bachelor principal investigator
Instituto de Medicina Integral Professor Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hammock positioning in people with Infant, Premature, Diseases, run by Instituto Materno Infantil Prof. Fernando Figueira 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 17 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?
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?
Increase in Muscle activity (time frame: 24 hours). 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 17 Aug 2017.