Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning

Not Applicable

• Conditions: Infant, Premature, Diseases
• Interventions: Other: Hammock positioning

• Registration Number: NCT02668107
• Lead Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-17
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Increase in Muscle activity	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.

Trial Locations

Locations (1)

Instituto de Medicina Integral Professor Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil