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Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning

Primary Purpose

Infant, Premature, Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hammock positioning
Sponsored by
Instituto Materno Infantil Prof. Fernando Figueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infant, Premature, Diseases

Eligibility Criteria

1 Day - 20 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto de Medicina Integral Professor Fernando Figueira

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group (Hammock positioning)

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2016
Last Updated
August 15, 2017
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
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1. Study Identification

Unique Protocol Identification Number
NCT02668107
Brief Title
Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning
Official Title
Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning : a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (Hammock positioning)
Arm Type
Active Comparator
Arm Description
Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Those selected for the control group (CG) will be placed in the incubator following the service routine.
Intervention Type
Other
Intervention Name(s)
Hammock positioning
Intervention Description
Babies in the intervention group (IG), will be positioned supine in a hammock(hammock positioning) in the incubator, with the appropriate postural adjustments.
Primary Outcome Measure Information:
Title
Increase in Muscle activity
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
20 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Eyre, Bachelor
Organizational Affiliation
Instituto de Medicina Integral Professor Fernando Figueira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Integral Professor Fernando Figueira
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-550
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning

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