Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock

Study Overview
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Brief Summary
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object name: Lung ultrasound-guided fluid resuscitation in neonatal septic shock. type of study: prospective observational study. goal of study: The effects of severe ultrasound-assisted fluid resuscitation and conventional fluid resuscitation on the prognosis of children with neonatal septic shock were compared to evaluate the application value of the two techniques in fluid resuscitation of neonatal septic shock. research design: In this study, children with neonatal septic shock diagnosed in the neonatal intensive care unit of the Second People 's Hospital of Guangdong Province from January 1,2022 to December 31,2023 were included in the population. According to the different monitoring methods used in conventional / clinical shock treatment, 30 cases of fluid resuscitation assisted by severe ultrasound, 30 cases of fluid resuscitation assisted by NICOM and 30 cases of conventional fluid resuscitation were collected, a total of 90 cases. ( 1 ) The demographic data, blood examination and microbiological examination data of the two groups at admission were collected. ( 2 ) The fluid volume, blood lactic acid, blood pressure, vasoactive drugs ( such as dopamine and epinephrine / norepinephrine ), mechanical ventilation, renal replacement therapy and antibiotic use were collected before fluid resuscitation. ( 3 ) The cumulative fluid infusion volume during fluid resuscitation ( 6 hours ), and the use of vasoactive drugs and mechanical ventilation for 6 hours were collected. ( 4 ) NICU hospitalization time, cumulative hospitalization time and mortality were collected. Data collection : ( 1 ) The demographic data, blood examination and microbiological examination data of the three groups at admission were collected. ( 2 ) The fluid volume, blood lactic acid, blood pressure, vasoactive drugs ( such as dopamine and adrenaline / norepinephrine ), mechanical ventilation, renal replacement therapy and antibiotic use before fluid resuscitation were collected. ( 3 ) The cumulative fluid infusion volume during fluid resuscitation ( 6 hours ), and the use of vasoactive drugs and mechanical ventilation for 6 hours were collected. ( 4 ) NICU hospitalization time, cumulative hospitalization time and mortality were collected.

Detailed Description
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Efficacy evaluation: The main efficacy criteria: NICU hospitalization time and cumulative hospitalization time, mortality. Secondary efficacy criteria: cumulative fluid volume during fluid resuscitation (6 hours), and use of vasoactive drugs and mechanical ventilation for 6 hours.

Official Title
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Study on the Application Value of Fluid Resuscitation Guided by Lung Ultrasound in Neonatal Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Diagnostic Test: lung ultrasound-guided fluid resuscitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born less than 28 days on admission ; In line with the diagnostic criteria for neonatal septic shock in the ' 2020 International Guidelines for Saving Sepsis Campaign : Management of Sepsis-related Organ Dysfunction in Children ' ; For children diagnosed with septic shock, fluid resuscitation should be performed according to the routine diagnosis and treatment. The legal guardian has signed the informed consent. Exclusion Criteria: combined with neurogenic shock, trauma and hemorrhagic shock ; symptomatic patent ductus arteriosus ; combined with congenital heart disease ; give up treatment or death within 24 hours of admission ; The legal guardian refused to participate in the study ; Key information and information missing.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No intervention will be given | |
| Sham Comparator: traditional group<br>Non-invasive cardiac output monitoring ( NICOM ) assisted fluid resuscitation. | Diagnostic Test: lung ultrasound-guided fluid resuscitation<br>* For the LUGFR group, therapy was applied based on the same treatment guidelines, and initial lung ultrasonography was performed after enrollment as baseline assessment of lung. The lung ultrasound was conducted using the Doppler ultrasound diagnostic instrument (Philips CX50) at a probe frequency range of 8 to 12 MHz. Lung ultrasonography was conducted using the 12-region method that included the anterior, lateral, and posterior walls on both sides of the lung, which was focused on the condition of A-lines, B-lines (including confluent B-line and compact B-lines), lung consolidation and pleural effusion<br>|
| Experimental: LUGFR group<br>lung ultrasound-guided fluid resuscitation | Diagnostic Test: lung ultrasound-guided fluid resuscitation<br>* For the LUGFR group, therapy was applied based on the same treatment guidelines, and initial lung ultrasonography was performed after enrollment as baseline assessment of lung. The lung ultrasound was conducted using the Doppler ultrasound diagnostic instrument (Philips CX50) at a probe frequency range of 8 to 12 MHz. Lung ultrasonography was conducted using the 12-region method that included the anterior, lateral, and posterior walls on both sides of the lung, which was focused on the condition of A-lines, B-lines (including confluent B-line and compact B-lines), lung consolidation and pleural effusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalization time | Primary indicator | Within 2 weeks | 
| mortality | Primary indicator | Within 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative fluid volume | Secondary Outcome | Within 2 weeks | 
| Use of vasoactive drugs | Secondary Outcome | Within 2 weeks | 
| Use of mechanical auxiliary gas | Secondary Outcome | Within 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal septic shock, Lung ultrasound, fluid resuscitation