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NCT Number: NCT06144463

Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lung ultrasound-guided fluid resuscitation

Diagnostic Test

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

Primary outcomes

  1. hospitalization time

    Time frame: Within 2 weeks

    Primary indicator

  2. mortality

    Time frame: Within 2 weeks

    Primary indicator

Secondary outcomes

  1. Cumulative fluid volume

    Time frame: Within 2 weeks

    Secondary Outcome

  2. Use of vasoactive drugs

    Time frame: Within 2 weeks

    Secondary Outcome

  3. Use of mechanical auxiliary gas

    Time frame: Within 2 weeks

    Secondary Outcome

Sponsors and collaborators

Lead sponsor

Guangdong Second Provincial General Hospital

Other

Registry information

Official study title

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

Acronym: LUGFRINSS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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