Overview

This trial is active, not recruiting.

Condition infant, premature, diseases
Treatment hammock positioning
Sponsor Instituto Materno Infantil Prof. Fernando Figueira
Start date August 2015
End date February 2017
Trial size 65 participants
Trial identifier NCT02668107, CAAE 43874915.0.0000.5201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments.
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)
Those selected for the control group (CG) will be placed in the incubator following the service routine.

Primary Outcomes

Measure
Increase in Muscle activity
time frame: 24 hours

Eligibility Criteria

Male or female participants up to 20 days old.

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

Additional Information

Official title Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning : a Randomized Clinical Trial
Principal investigator Isabel Eyre, Bachelor
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Instituto Materno Infantil Prof. Fernando Figueira.