Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning

Infant, Premature, Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02668107
• Other study ID #: CAAE 43874915.0.0000.5201
• Status: Active, not recruiting
• Phase: N/A
• First received: January 26, 2016
• Last updated: August 15, 2017
• Start date: August 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2017
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 20 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Professor Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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