Suspendu

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

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

hammock

+ containment nest

Dispositif médical
Qui peut participer

Maladies génito-urinaires+9

+ Maladies urogénitales féminines et complications de la grossesse

+ Complications de l'accouchement obstétrique

+14 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : décembre 2015
Voir le détail du protocole

Résumé

Sponsor principalUniversidade Federal de Pernambuco
Contacts de l'étudeBruna F Silva, PT
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 décembre 2015

Date à laquelle le premier participant a commencé l'étude.

The study population will consist of moderately preterm newborns, attended by SUS, admitted to the NICU of HBL or HC UFPE. From randomized samples with preterm infants born in the HBL or HC, and are admitted to the NICU, will be obtained two groups, one for positioning in hammock (experimental group) and the other in incubator containment nest "U" ( group control). The sample will consist of 30 premature babies, 15 in each group. The allocation of the PN is made in two blocks, using the site randomization.com, so that the block 1 corresponds to the group with hammock and positioning block 2, the group subjected to the usual positioning in the incubator, which at the study site it is "containment nest in U". The recruitment of premature will be conducted by researcher 1, which will identify premature the NICU potentially eligible for the study, invite the parents or guardians to sign the consent form and clear, and then make the screening (inclusion) of the truly eligible babies after filling in a checklist of eligibility criteria, always registering why exclude the other. Then, the PN will be wrapped in a sheet and carried by the investigator 1 to the support area of neonatal sector, located within the NICU, and where they will be placed on the counter, a mattress (incubator) and electromyography to carry out the assessments. Since each premature will be submitted to reviews of protocol only when alert according to the state 4 or 5 (warning with little activity and alert to activity) of the Brazelton scale, evaluations will be carried out between meals, avoiding the baby stay angry or sleepy. This procedure will be followed regardless of the position that the baby will be submitted later. In the event, the evaluation will be interrupted, and the baby will be taken back to the incubator, receiving the assistance that is required, and will be excluded from the study. The electromyographic and clinical evaluations will be conducted by researcher 1, preventing the masking at this stage. The results obtained in the evaluations (global posture, gathering maneuvers arm and popliteal angle, via video recording, and the electromyographic signal) will be analyzed by researchers 2 and 3, blind research. The EMG will be made via a portable electromyography surface mark with four channels, which will be connected to a laptop, and double electrode surface, specially developed for use in EMG, disposable, adhesive gel Ag conductor / AgCl, intended for clinical and research use. According to SENIAM recommendations (EMG Surface European consortium for the Non-Invasive Assessment of Muscles), the pads will be fixed between the motor point and the tendon of the flexor muscles: rectus abdominis, biceps and hamstrings, and the electrode reference on the left lateral malleolus. Three channels will be used to record the electrical activity unilateral (right of all PN) and simultaneously in the three above-mentioned places, so that the spontaneous muscle activity baby is captured under the same conditions. The PTN will be submitted for evaluation by surface EMG while simultaneously performed the clinical evaluation of tone with the neurological test Dubowitz. It will only be applied to size of that test by referring to the tone match the focus of this research, and only the chosen sub-items that do not require much manipulation premature. These sub-items refer to the observation of global postural baby standard (which observe the legs and the upper to the trunk in the supine position), the arms collection operation (in which it analyzes the by rapid extension muscle strength elbow, and elbow flexion speed and angle he takes after three seconds long maintained the elbow), and popliteal angle (baby knee is positioned over the abdomen and exercises to gentle pressure with the index finger behind the ankle in order to increase the popliteal angle, the maximum angle observing obtained. Test up one leg at a time). Thus, after placement of the electrodes, it will initially be observed and recorded the signal picked up by EMG of the rectus abdominis muscles, biceps and hamstrings for 30 seconds, representing the muscle tone baby home. Simultaneously to this first record in the EMG, the researcher will make the clinical evaluation of the tone by observing the posture of premature standard. Then, still using the EMG in association with the Dubowitz Test, evaluation of the maneuvers of the popliteal angle and gathering arms are made that lead to be performed 30 seconds each. Similarly, in parallel to this clinical evaluation of tone, will be made in the records EMG muscle activity of the biceps and hamstrings related to muscle resistance to stretching caused the Dubowitz test. All evaluations of muscle activity (EMG and clinical) will be recorded on video using a digital camera Sony® brand (model 1000 Cyber Shot 7.2 Mega Pixels), attached to a tripod positioned in order to capture the image of the entire PN body, so researchers can analyze 2 and 3 evaluation results, but also so that we can resolve any doubt about the future evaluations. After the evaluations, the researcher first position the PN in hammock or incubator containment nest "U", according to the randomization envelope content to it corresonding. The hammock was made of knitted fabric (100% cotton) for improved tactile comfort and prevent allergic reactions in the baby, and its dimensions follow the determinations that are in the process of patenting requested by Roberta Tenorio and Roberta Bione the National Institute of Industrial Property (INPI) in 2014, with number 19140000184 protocol and order number BR 20 2014 017 809 6. In the control group, the position will follow the routine procedure of HBL and HC, which is the use of containment nests "U" , made with rolled sheet placed on the mattress of the incubator and covered by another sheet. To identify if there was adaptation of premature positioning, physiological parameters (RR, HR and SaO2) and motor behavior (approach reactions and Withdrawal) shall be observed and recorded 5 minutes before the positioning in the hammock or incubators containment nest "U" immediately following (1 minute), after 5minutes and 10 minutes. The behavioral state of the newborn will be given by the presence or absence of specific movements welfare indicators (Approach reactions - hands to her mouth / face, holding hands, gripping motion, curling up on itself); and specific movements of stress indicators (Withdrawal reactions - aircraft wing, greeting, removal of the fingers, sitting in the air, arching). If the baby does not display any of these reactions at predefined times, the comfort will be checked only by physiological indicators. HR and SaO2 will be obtained by the pulse oximeter, and the FR will be obtained by the number of breaths per minute count made by the researcher 1. In order to detect any complications during the positioning, continuous monitoring of physiological parameters will be baby both by the researcher as one by the nursing staff of the NICU as routine neonatal sector. If there apnea situations, desaturation or no adjustment to the positioning in the hammock, the baby will be removed from this position and use the hammock will be discontinued, but should be placed in an incubator with containment nest "U" (routine neonatal HBL sector and HC), excluding the study of preterm infants and considering it as sample loss. The first stage assessment will be before the positioning, being named T0. At the end of about 8 positioning daylight hours, babies are taken from the hammock, being positioned according to routine neonatal sector (in containment nest "U" in the incubator) for the nighttime. All of the protocol tone evaluations will also be repeated the next day, 24 hours after the beginning of the positioning, both for the group that was placed in the hammock in the group that was placed in the incubator containment nest "U". This second assessment will be called T1. Again, after about 8 hours of daytime position, the baby will be removed from the hammock or position "U" for the nighttime. The final evaluation will take place the next morning, approximately 48 hours after the start of positioning hammock or containment nest, a time called T2. Also, all revaluations will be filmed for any questions that may arise.

Titre officielHammock Positioning's Influence on the Electromyographic Activity in the Flexor Muscles in Newborn Preterm
NCT02621996
Sponsor principalUniversidade Federal de Pernambuco
Contacts de l'étudeBruna F Silva, PT
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

20 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies génito-urinairesMaladies urogénitales féminines et complications de la grossesseComplications de l'accouchement obstétriqueTravail obstétrical prématuréHypotonie musculaireMaladies du système nerveuxManifestations NeurologiquesComplications de la grossesseSignes et symptômesConditions pathologiques, signes et symptômesManifestations NeuromusculairesNaissance Prématurée

Critères

4 critères d'inclusion nécessaires pour participer
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

10 critères d'exclusion empêchent la participation
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;

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
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.

Groupe II

Comparateur actif
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.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Hospital Barão de Lucena

Recife, BrazilOuvrir Hospital Barão de Lucena dans Google Maps
Suspendu1 Centres d'Étude