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Clinical Trials/NCT02668107
NCT02668107
Unknown
N/A

Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning : a Randomized Clinical Trial

Instituto Materno Infantil Prof. Fernando Figueira1 site in 1 country65 target enrollmentAugust 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant, Premature, Diseases
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
Enrollment
65
Locations
1
Primary Endpoint
Increase in Muscle activity
Last Updated
8 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
Responsible Party
Principal Investigator
Principal Investigator

Isabel Cristina de Almeida Eyre

Mrs

Instituto Materno Infantil Prof. Fernando Figueira

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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