Hammock Positioning's Influence on the Electromyographic Activity in the Flexor Muscles in Newborn Preterm

NCT02621996 | Unknown DMC

• 1 other identifier: 44943415.5.0000.5208
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The individual who is born premature, in addition to a CNS still in accelerated training suffers early loss of intrauterine restraint, conditions that promote hypotonia characteristic of premature birth. Given this hypotonia associated with musculoskeletal immaturity when improperly positioned in the incubator for an extended period, the PN can develop joint contractures and postural imbalances that, in most cases, are transitory, however can become persistent, causing delay in their Motor development. The aim of this study is to analyze the influence of the positioning of preterm infants in the incubator hammock on the tone and the myoelectric activity of the rectus abdominis flexor muscles, biceps and hamstrings. Study type controlled, randomized, double-blind, to be carried out from November 2015 to April 2016 will be obtained two groups, control (in containment nest "U") and experimental (with hammock) to from randomized samples with premature births in Barao de Lucena Hospital or the Hospital das Clinicas, UFPE, the Intermediate Care Units (ICU) Neonatal. The sample will consist of 30 premature. To collect, pulse oximeter will be used, electromyography, neurological testing Dubowitz and recording behavioral responses. Each baby will be accompanied for about 8 hours daytime placement for two days and three evaluations performed.

Conditions

Preterm Birth

Keywords

Surface Electromyography; Hypotonia; Patient Positioning

Outcome Measures

Primary Outcomes (2)

• Changes on Root Means Square

  The evaluation with the EMG, the record average amplitude will be made of myoelectric signals in microvolts for 30 seconds, with the baby in spontaneous movement in the supine position for 30 seconds while the implementation of gathering maneuver arm, and 30 seconds while it is performed the maneuver of the popliteal angle. The electromyographic signals are picked up by electrodes, amplified and filtered in order to clear the most of the noise signal. For processing the data, the Miographic (Miotec Biomedical Equipment-Brazil) software, which allows the signal representation in Root Mean Square (RMS) is used.

  72 hours

• Changes on muscle tone

  The clinical evaluation of tone will be realized with the neurological test Dubowitz. Initially, the researcher will make the clinical evaluation of the tone by observing the posture of premature standard. Then, the evaluation of the maneuvers of the popliteal angle and gathering arms are made that lead to be performed 30 seconds each. This clinical evaluation of tone will measure the muscle resistance to stretching and the final angles of the elbow and knee right caused the Dubowitz test. Clinical evaluation of the test tone with neurological Dubowitz, raw scores are generated (1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 to 5) for each sub-item (posture global, gathering maneuver arm, right popliteal angle), which will be converted into qualitative scores (1 = "normal tone", 0.5 = "border" and 0 = "abnormal"), according to gestational age at birth , according to the conversion table raw scores of Dubowitz.

  72 hours

Secondary Outcomes (1)

• Changes on behavioral state

  5 minutes before positioning and 1 minute, 5 minutes, and 10 minutes after positioning" minutes

Other Outcomes (3)

• Changes on heart rate

  5 minutes before positioning and 1 minute, 5 minutes, and 10 minutes after positioning" minutes

• Changes on respiratory rate

  5 minutes before positioning and 1 minute, 5 minutes, and 10 minutes after positioning" minutes

• Changes on oxygen saturation

  5 minutes before positioning and 1 minute, 5 minutes, and 10 minutes after positioning" minutes

Study Arms (2)

Hammock group

EXPERIMENTAL

PN who will be positioned in hammock inside the incubator will be with the high trunk to about the 30th, and will be used a roll of restraint in the neck by keeping a slight lordosis to avoid suffocation risks. In two days of placement, should remain about 8 hours in the hammock, being removed during cleaning procedures, diet and medical evaluation and then immediately replaced in the hammock. The alternation of decubitus (right side, supine and left lateral) should be performed whenever the child is manipulated for these procedures.

Device: hammock

control group

ACTIVE COMPARATOR

In the control group, the position will follow the routine procedure of the Hospital Barão de Lucena, consisting of the use of restraint nests "U", made with rolled sheet placed on the mattress of the incubator and covered by another sheet. The control group incubators will also be inclined at 30 ° as routine service. During the 8 position, switching the supine will also be held, side left and side right after the baby handling to cleaning procedures, diet and medical evaluation.

Device: containment nest

Interventions

hammock DEVICE

PN who will be positioned in hammock inside the incubator will be with the high trunk to about the 30th, and will be used a roll of restraint in the neck by keeping a slight lordosis to avoid suffocation risks. In two days of placement, should remain about 8 hours in the hammock, being removed during cleaning procedures, diet and medical evaluation and then immediately replaced in the hammock. The alternation of decubitus (right side, supine and left lateral) should be performed whenever the child is manipulated for these procedures.

Hammock group

containment nest DEVICE

In the control group, the position will follow the routine procedure of the Hospital Barão de Lucena, consisting of the use of restraint nests "U", made with rolled sheet placed on the mattress of the incubator and covered by another sheet. The control group incubators will also be inclined at 30 ° as routine service. During the 8 position, switching the supine will also be held, side left and side right after the baby handling to cleaning procedures, diet and medical evaluation.

control group

Eligibility Criteria

• Age: 48 Hours - 1 Week
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Be moderate preterm infants born with gestational ages between 31-35 weeks;
• Postnatal age from 48 hours to one week of life;
• Clinical Stability: respiratory rate between 30-60 rpm, heart rate between 120-160 bpm, oxygen saturation (SaO2) above 89%, the absence of signs of respiratory distress (Silverman-Andersen Bulletin), no cyanosis or pallor and pain / discomfort;
• Appropriate behavioral State: State 4 (inactive alert) or 5 (active alert) Brazelton

You may not qualify if:

• APGAR less than 7 at 5˚ minute;
• Rating as small for gestational age (SGA), according to gestational age ratio chart with birth weight;
• Being in use of drugs that interfere with the state of consciousness, as sedatives;
• preterm infants undergoing phototherapy, oxygen therapy or venous access;
• preterm infants undergoing mechanical ventilation;
• Intracranial hemorrhage grade III or IV or periventricular leukomalacia (diagnosed by ultrasound transfontanellar recorded in medical records);
• CNS infection (meningitis and encephalitis);
• seizure of History;
• Necrotizing enterocolitis at the time of examination;
• Congenital malformations, genetic syndromes, neurological disorders or diagnosed congenital STORCH infectious diseases (syphilis, toxoplasmosis, rubella, cytomegalovirus and herpes).

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Hospital Barão de Lucena

Recife, Pernambuco, 50731000, Brazil

Location

MeSH Terms

Conditions

Premature Birth; Muscle Hypotonia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karla F Lambertz, PhD

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

• Carine Wiesiolek, PhD

  Universidade Federal de Pernambuco

  STUDY CHAIR

Central Study Contacts

Bruna F Silva, PT

CONTACT

+55 (83) 987808492; brunajardim@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist (master student)

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 4, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

BR (1)