Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05145114
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2021-10-04
Brief Title:
Hemodynamic Repercussions in Different Therapeutic Positions in Premature Newborn
Sponsor:
Amazon University
Organization:
Amazon University
Study Overview
Official Title:
Hemodynamic Repercussions in Different Therapeutic Positions in Premature Newborn Under Invasive Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 TermThen access to data related to the newborns 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 newborns 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 babys 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 newborns 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 p005
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 p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None