Impact of Echocardiography on Management of Critically Ill Neonates

Обзор

The goal of the study was to estimate the outcome (mortality and morbidity) among hemodynamically unstable neonates, as well as the time to return to hemodynamic stability following the use of ECHO in the management of hemodynamically unstable neonates.

Подробное описание

-All patients will be subjected to : Full clinical examination for manifestation or signs of hemodynamic instability and daily thereafter until discharge.

An echocardiographic assessment using Vivid T8 Pro ( GE MEDICAL SYSTEMS ( CHINA ) CO, LTD.) is done if manifestations of hemodynamic instability or shock appeared.

The imaging planes were identified by transducer location (subxiphoid, apical, parasternal, suprasternal notch, and right parasternal). The segmental approach was used to describe all of the major cardiovascular structures in sequence.

Suggested plan of management will be as the following:

1. Neonates with low LVO and impaired left ventricular contractility: dobutamine at a dose of 5-20 μg/kg/min was given, and if no improvement, volume expansion as a single intravenous infusion of 10-20 ml/kg of the crystalloid solution was given. If still no improvement, hydrocortisone at a dose of 1 mg/kg every 4 h was added. If improvement was not achieved, epinephrine was added at a dose of 0.05-2.6 μg/kg/min \[11\]. 2. Neonates with LVO and hypovolemia (under-filled left ventricle): volume expansion as a single intravenous infusion of 10-20 ml/kg of the crystalloid solution will be given. If still no improvement, it was repeated \[11\]. 3. Neonates with normal or high LVO without PDA: dopamine at a dose of 5-20 μg/kg/min is given. If no improvement, hydrocortisone at a dose of 1 mg/kg every 4 h is added. If improvement was not achieved, epinephrine is added at a dose of 0.05-2.6 μg/kg/min \[11\]. 4. Neonates with normal or high LVO and hemodynamically significant PDA: PDA will be treated either medically or surgically \[11\]. 5. During the current study period, all previously mentioned hemodynamically unstable neonate values were compared to values collected from the controlled group (200 hemodynamically stable neonates). 6. Neonates will be monitored regularly and subjected to repeated echocardiographic and clinical examinations to detect clinical and laboratory findings suggestive of hemodynamic instability or shock.

Вмешательства

• Устройство Echocardiography
  Functional echocardiography assessment

Первичные конечные точки

• Functional echocardiography ( ejection fraction using M mode echocardiography) [Срок оценки: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)]
• Functional echocardiography fraction shortening by M mode echocardiography [Срок оценки: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)]
• Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography [Срок оценки: Repeat echocardiographic assessment 5 days after the first echo assessment]
• Assessment of pulmonary hypertension [Срок оценки: Repeat echocardiographic assessment on a daily basis ( 24 hours interval) following proposed treatment of pulmonary hypertension]
• Assessment of LV cardiac index [Срок оценки: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)]
• Assessment of RV cardiac index [Срок оценки: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)]
• Assessment of SVC flow [Срок оценки: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)]
• Assessment of RV function [Срок оценки: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)]

Критерии участия

Критерии включения

• All neonates ( age 0 to 28 days) admitted to the NICU of Sohag University Hospital during the period of the study in whom manifestations of hemodynamic instability or critical illness were elected regardless of gestational age, weight, gender, or type of disease.

Критерии исключения

• Failure to obtain informed consent .
• Presence of congenital heart disease apart from PDA , PFO \& small ASD .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Египет · 1 центр

• Sohag University Hospital — Sohag

Публикации

• Kluckow M, Seri I, Evans N. Functional echocardiography: an emerging clinical tool for the neonatologist. J Pediatr. 2007 Feb;150(2):125-30. doi: 10.1016/j.jpeds.2006.10.056. No abstract available. PMID 17236886
• Soleymani S, Borzage M, Seri I. Hemodynamic monitoring in neonates: advances and challenges. J Perinatol. 2010 Oct;30 Suppl:S38-45. doi: 10.1038/jp.2010.101. PMID 20877406
• Tibby SM, Hatherill M, Marsh MJ, Murdoch IA. Clinicians' abilities to estimate cardiac index in ventilated children and infants. Arch Dis Child. 1997 Dec;77(6):516-8. doi: 10.1136/adc.77.6.516. PMID 9496187
• Egan JR, Festa M, Cole AD, Nunn GR, Gillis J, Winlaw DS. Clinical assessment of cardiac performance in infants and children following cardiac surgery. Intensive Care Med. 2005 Apr;31(4):568-73. doi: 10.1007/s00134-005-2569-5. Epub 2005 Feb 15. PMID 15711976
• de Boode WP. Clinical monitoring of systemic hemodynamics in critically ill newborns. Early Hum Dev. 2010 Mar;86(3):137-41. doi: 10.1016/j.earlhumdev.2010.01.031. Epub 2010 Feb 20. PMID 20171815
• McNamara PJ, Sehgal A. Towards rational management of the patent ductus arteriosus: the need for disease staging. Arch Dis Child Fetal Neonatal Ed. 2007 Nov;92(6):F424-7. doi: 10.1136/adc.2007.118117. PMID 17951547
• Sehgal A, McNamara PJ. Does point-of-care functional echocardiography enhance cardiovascular care in the NICU? J Perinatol. 2008 Nov;28(11):729-35. doi: 10.1038/jp.2008.100. Epub 2008 Jul 17. PMID 18633423

Идентификаторы

NCT: NCT06533787 · Soh-Med-24-07-08MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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