NCT05145114

Hemodynamic Repercussions in Different Therapeutic Positions in Premature Newborn

Completed NA Last updated 6 December 2021

What this trial tests

NA trial testing THERAPEUTIC POSITIONS in Therapeutic Position in 30 participants. Completed in 15 January 2021.

Timeline

6 May 2020

Primary endpoint
1 October 2020

15 January 2021

Quick facts

Lead sponsor	Amazon University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	30
Start date	6 May 2020
Primary completion	1 October 2020
Estimated completion	15 January 2021
Sites	1 location across Brazil

Drugs / interventions tested

• THERAPEUTIC POSITIONS

Conditions studied

• Therapeutic Position — all drugs for Therapeutic Position →
• Hemodynamics — all drugs for Hemodynamics →

Sponsor

Amazon University

Who can join

Adults 1 Day to 37 Weeks, any sex, with Therapeutic Position or Hemodynamics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.