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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | No intervention will be given | |
| traditional group | Sham Comparator | Non-invasive cardiac output monitoring ( NICOM ) assisted fluid resuscitation. |
|
| LUGFR group | Experimental | lung ultrasound-guided fluid resuscitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| hospitalization time | Primary indicator | Within 2 weeks |
| mortality | Primary indicator | Within 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative fluid volume | Secondary Outcome | Within 2 weeks |
| Use of vasoactive drugs | Secondary Outcome | Within 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhenyu Liang, Master | Department of Pediatrics, Guangdong Second Provincial General Hospital, Guangzhou, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | 510317 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32093763 | Background | Singh Y, Tissot C, Fraga MV, Yousef N, Cortes RG, Lopez J, Sanchez-de-Toledo J, Brierley J, Colunga JM, Raffaj D, Da Cruz E, Durand P, Kenderessy P, Lang HJ, Nishisaki A, Kneyber MC, Tissieres P, Conlon TW, De Luca D. International evidence-based guidelines on Point of Care Ultrasound (POCUS) for critically ill neonates and children issued by the POCUS Working Group of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). Crit Care. 2020 Feb 24;24(1):65. doi: 10.1186/s13054-020-2787-9. | |
| 38095714 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2021 | Nov 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2021 | Nov 16, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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|
| Use of mechanical auxiliary gas | Secondary Outcome | Within 2 weeks |
| Derived |
| Huang D, You C, Mai X, Li L, Meng Q, Liang Z. Lung ultrasound-guided fluid resuscitation in neonatal septic shock: A randomized controlled trial. Eur J Pediatr. 2024 Mar;183(3):1255-1263. doi: 10.1007/s00431-023-05371-9. Epub 2023 Dec 14. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |