Hemodynamic Repercussions in Different Therapeutic Positions in Premature Newborn
Condition: Therapeutic Position; Hemodynamics
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Introduction: Prematurity refers to babies born before 37 weeks of gestation that through
      technological advances survival is increasing, since most of them are referred to the
      Neonatal Intensive Care Unit (NICU). Hemodynamic monitoring is of fundamental importance in
      the care provided to critically ill patients and mechanical ventilation (MV) is often used
      for the recovery and maintenance of newborns, especially premature infants with any pathology
      that causes cardiorespiratory failure. Considering this, it is necessary to look for ways to
      treat these newborns (NB), being the therapeutic positioning one of the simplest and most
      fundamental to reduce the consequences of the mechanical advantages of the respiratory system
      of newborns. Objective: To evaluate the hemodynamic repercussions in the various therapeutic
      positions in premature newborns under invasive mechanical ventilation. Method: A field study
      to be conducted will be randomized on an experimental, quantitative and descriptive
      character. It will be developed at the Santa Casa de Misericórdia do Pará Foundation
      (FSCMPa), in the Neonatal Intensive Care Unit. The population to be evaluated will be preterm
      infants with gestational age ≤37 weeks, on invasive mechanical ventilation, with no
      congenital malformations, with the diagnosis of intracranial hemorrhage and that those
      responsible, after being informed, authorized to participate in the research. Being excluded
      the preterm infants without legal companion, who are affected by any unfavorable clinical
      condition, which makes the change of unfeasible position, children with neuromuscular
      diseases, tracheostomized. A sample will be randomly selected in groups: Prono Group (GP),
      Supine Group (GS) and Lateral Decubitus Group (GDL). The decubitus to be adopted for each
      research subject will then be registered by the researcher in a specific form, recording as
      respiratory cardiological responses: respiratory rate (RR), heart rate (HR) and peripheral
      oxygen saturation (SPO2), temperature (T) and pressure blood pressure (BP). Such clinical
      responses will be noted prior to NB positioning, then positioned according to the group to
      which they will belong for 30 minutes, and then there will be another selection of vital
      signs.
    

Detailed description: 
      The present field study to be carried out will be controlled clinical trial, randomized,
      experimental, quantitative and analytical. The research will be carried out in accordance
      with the ethical aspects recommended in the Declaration of Helsinki and Nuremberg Code, and
      by the research standards that may involve human beings of the National Health Council.
      Parents and guardians of premature newborns eligible for the survey will be invited to
      consent to the participation of newborns in the survey, in which the purpose, objectives and
      procedures of the research will be explained, requesting the signature of the Informed
      Consent Form and Informed and the Informed Consent Term.Then, access to data related to the
      newborn's medical record will be performed through the presentation of the Data Use
      Commitment Term. The sample will be randomly separated into groups: Prone Group, Supine Group
      and Lateral Decubitus Group. The decubitus to be adopted for each research subject will then
      be registered by the researcher in a specific form that will contain the following
      information: identification, gender, Apgar in the first and fifth minutes, GA, weight, use of
      surfactant and amount of doses, time of use of mechanical ventilation, length of hospital
      stay and others, with this information being obtained from the newborn's medical record, this
      step will provide data that will characterize the sample. For data acquisition via medical
      records, the researcher will submit the consent form for data use. The most used
      physiological parameters are vital signs, such as heart rate and percutaneous oxygen
      saturation, as they are the most easily observed responses. The most used physiological
      parameters are vital signs, such as heart rate and percutaneous oxygen saturation, as they
      are the most easily observed responses. This is due to the fact that babies who need
      intensive care are usually under these assessments constantly by pulse oximeters and because
      they have been the best scientifically validated among the physiological responses. The vital
      signs of heart rate (HR), often respiratory rate (RR) and blood pressure (BP), can be
      influenced by the infant 's age and health condition. Peripheral oxygen saturation may have
      its results altered by the baby's behavioral state and pulmonary conditions. The assessment
      of HR and RR, indirectly, may reflect respiratory discomfort, it is common to observe
      tachypnea and some patients present tachycardia for not accepting or tolerating the
      positioning they are submitted. To record the monitoring of cardiorespiratory physiological
      responses, an interval of 2 hours after the diet will be respected so that there are no
      complications during the procedure. The respiratory rate (RR) will be collected for this, the
      thoracic incursions of the patients will be observed for one minute, counted on a digital
      clock, and to measure the heart rate (HR) and peripheral oxygen saturation, a pulse oximeter
      will be used, provided by the institution , positioned on the newborn's foot. Axillary
      temperature will also be measured with a thermometer specific to each NB and blood pressure
      with a device from the institution.

      Such clinical responses will be noted before the positioning of the NB, then participants
      will be positioned according to the group they belong to for 30 minutes, and then there will
      be a new verification of vital signs. During the time they are positioned, the RN will be
      asked not to receive routine procedures from the NICU or any stimulation by the health team.
      Only in cases that require urgent intervention. Being evaluated 1 times a day in the morning
      shift for two weeks. The collected data will be stored in Microsoft Excel® spreadsheets ,
      which will serve to perform a simple descriptive statistics that will be presented in
      percentages, arranged in graphs and tables. Statistical analysis will be based on the use of
      statistical tests that best fit the study proposal through the Biostat ® statistical package
      . In order to know the profile of the data, the Shapiro-Wilk test will be applied to verify
      whether the data under analysis presented normality. To compare the mean values of the data,
      the ANOVA test will be performed, followed by the Newman-Keuls multiple comparison test for
      the variables: heart rate, respiratory rate, oxygen saturation and the Studen t test for the
      variables: blood pressure and axillary temperature. In all tests, the level for rejecting the
      null hypothesis will be set at 5% (p<0.05).
    

Intervention name(s): THERAPEUTIC POSITIONS
Intervention type(s): Procedure
Intervention description(s): Therapeutic positioning includes placing infants in prone (prone), supine, side (lateral) decubitus, using restraint devices to provide support, reassurance and physiological stability.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Premature newborn; Patient Positioning; Mechanical ventilation