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Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06144463
Acronym
LUGFRINSS
Enrollment
72
Registered
2023-11-22
Start date
2022-01-01
Completion date
2023-06-30
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Lung ultrasound, fluid resuscitation, neonatal septic shock

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTlung ultrasound-guided fluid resuscitation

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

Sponsors

Guangdong Second Provincial General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

1. Born less than 28 days on admission ; 2. 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 ' ; 3. For children diagnosed with septic shock, fluid resuscitation should be performed according to the routine diagnosis and treatment. 4. The legal guardian has signed the informed consent.

Exclusion criteria

1. combined with neurogenic shock, trauma and hemorrhagic shock ; 2. symptomatic patent ductus arteriosus ; 3. combined with congenital heart disease ; 4. give up treatment or death within 24 hours of admission ; 5. The legal guardian refused to participate in the study ; 6. Key information and information missing.

Design outcomes

Primary

MeasureTime frameDescription
hospitalization timeWithin 2 weeksPrimary indicator
mortalityWithin 2 weeksPrimary indicator

Secondary

MeasureTime frameDescription
Cumulative fluid volumeWithin 2 weeksSecondary Outcome
Use of vasoactive drugsWithin 2 weeksSecondary Outcome
Use of mechanical auxiliary gasWithin 2 weeksSecondary Outcome

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026