Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning

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

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.

Study Overview

• Status: Unknown
• Conditions: Infant, Premature, Diseases
• Intervention / Treatment: Other: Hammock positioning

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-550
      • Instituto de Medicina Integral Professor Fernando Figueira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
No Intervention: Control Group; Those selected for the control group (CG) will be placed in the incubator following the service routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira
• Investigators: Principal Investigator: Isabel Eyre, Bachelor, Instituto de Medicina Integral Professor Fernando Figueira

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases
• Other Study ID Numbers: CAAE 43874915.0.0000.5201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No