Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning

NCT ID: NCT02668107

Last Updated: 2017-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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

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Infant, Premature, Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group (Hammock positioning)

Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments.

Group Type ACTIVE_COMPARATOR

Hammock positioning

Intervention Type OTHER

Babies in the intervention group (IG), will be positioned supine in a hammock(hammock positioning) in the incubator, with the appropriate postural adjustments.

Control Group

Those selected for the control group (CG) will be placed in the incubator following the service routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hammock positioning

Babies in the intervention group (IG), will be positioned supine in a hammock(hammock positioning) in the incubator, with the appropriate postural adjustments.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Genetic syndromes
* Congenital malformations
* Sepsis with meningitis
* Orthopedic and musculoskeletal alterations
Minimum Eligible Age

1 Day

Maximum Eligible Age

20 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role lead

Responsible Party

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Isabel Cristina de Almeida Eyre

Mrs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabel Eyre, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Integral Professor Fernando Figueira

Locations

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Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE 43874915.0.0000.5201

Identifier Type: -

Identifier Source: org_study_id

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