Functional echocardiography for management of shock in neonates - study protocol for a randomized controlled trial

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dc.contributor.authorMir, YAen_US
dc.contributor.authorChawla, Den_US
dc.contributor.authorJain, Sen_US
dc.contributor.authorKhurana, S.en_US
dc.date.accessioned2025-05-09T08:46:57Z
dc.date.available2025-05-09T08:46:57Z
dc.date.issued2024-12
dc.description.abstractBackground: Shock is common in sick neonates and is associated with a high mortality. Detection and management of shock by monitoring clinical parameters may be inadequate due to inconsistent association with tissue perfusion. We hypothesize that objective assessments of cardiac functions may help to match the pathophysiology of shock with the pharmacological action of a vasoactive drug. This may lead to earlier resolution of shock and reduced incidence of mortality or brain injury. To test this hypothesis, this study aims to evaluate the efficacy of adding functional echocardiography to standard clinical assessment in improving short-term outcome of neonates with clinical features of shock. Methods: This study will be an open-labeled randomized controlled trial, conducted in all inborn neonates born at >27 weeks of gestation who develop clinical signs of shock. Enrolled neonates will be randomized into two groups: the echo group and the control group. Neonates in the echo group will be assessed for management of shock by both standard clinical evaluation and functional echocardiography. Neonates in the control group will be assessed for the management of shock by standard clinical evaluation. Primary outcome will be survival without requirement of inotropic support at 72 hours of randomization. Secondary outcomes include time to hemodynamic stability, duration of inotropic support and incidence of abnormal cranial ultrasound. Conclusions: The trial intends to deduce the advantages, if any, of addition of functional echocardiography to standard clinical assessment to guide management of shock among preterm and term neonates. Trial registration: CTRI number: CTRI/2023/08/056672.en_US
dc.identifier.affiliationsDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, Punjab, Indiaen_US
dc.identifier.affiliationsDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, Punjab, Indiaen_US
dc.identifier.affiliationsDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, Punjab, Indiaen_US
dc.identifier.affiliationsDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, Punjab, Indiaen_US
dc.identifier.citationMir YA, Chawla D, Jain S, Khurana S.. Functional echocardiography for management of shock in neonates - study protocol for a randomized controlled trial . International Journal of Clinical Trials. 2024 Dec; 11(4): 289-298en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/243654
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber4en_US
dc.relation.volume11en_US
dc.source.urihttps://doi.org/10.18203/2349-3259.ijct20243332en_US
dc.subjectEchocardiographyen_US
dc.subjectShocken_US
dc.subjectBlood pressureen_US
dc.subjectNeonateen_US
dc.titleFunctional echocardiography for management of shock in neonates - study protocol for a randomized controlled trialen_US
dc.typeJournal Articleen_US
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