Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 26, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedAugust 17, 2017
August 1, 2017
2.2 years
January 26, 2016
August 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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: 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.
24 hours
Study Arms (2)
Intervention Group (Hammock positioning)
ACTIVE COMPARATORBabies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments.
Control Group
NO INTERVENTIONThose selected for the control group (CG) will be placed in the incubator following the service routine.
Interventions
Babies in the intervention group (IG), will be positioned supine in a hammock(hammock positioning) in the incubator, with the appropriate postural adjustments.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-550, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabel Eyre, Bachelor
Instituto de Medicina Integral Professor Fernando Figueira
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mrs
Study Record Dates
First Submitted
January 26, 2016
First Posted
January 29, 2016
Study Start
August 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
August 17, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share