跳至主要内容
临床试验/NCT07473804
NCT07473804招募中不适用

Syndromes With Neonatal Salt Loss: Not Only Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency (21OH-ISC)

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年4月14日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Measurement of the frequency of the different endocrine causes of salt loss not due to 21-hydroxylase-deficient CAH.

研究概览

简要总结

Neonatal salt loss can be caused not only by infections but also by rare endocrine disorders that resemble 21-hydroxylase deficiency but are not detected by neonatal screening. This study examines how often these conditions occur and describes their main clinical, genetic, and treatment features.

详细描述

Salt loss (SL) is a major cause of neonatal hospitalization and can be life-threatening if not promptly treated. It typically presents with hyponatremia (<130 mEq/L), often accompanied by hyperkalemia, hypochloremia, and metabolic acidosis. Clinical signs are nonspecific-including vomiting, irritability, hypotonia, and, in severe cases, seizures. Newborns are particularly vulnerable to electrolyte disturbances due to reduced glomerular filtration rate, immature distal nephrons, and transient aldosterone resistance.

While infectious gastroenteritis is the most common cause of neonatal SL, several endocrine disorders may present with the same clinical picture. The leading endocrine cause is primary adrenal insufficiency due to 21-hydroxylase deficiency, but other rare genetic conditions must be considered. These include aldosterone synthase deficiency, X-linked adrenal hypoplasia congenita (DAX-1/NR0B1 mutations), and types of pseudohypoaldosteronism, each characterized by impaired aldosterone production or action and early-life salt wasting.

Despite their heterogeneity, treatment generally relies on salt replacement, with mineralocorticoid and/or glucocorticoid therapy required in selected conditions. Only limited epidemiologic data exist; an Italian study (2006-2015) showed that 21-hydroxylase deficiency accounted for 37% of endocrine SL cases, while other congenital adrenal disorders contributed to 25%.

Neonatal screening programs detect 21-hydroxylase deficiency early, but other endocrine causes of SL remain unscreened and must be considered in differential diagnosis. This study aims to quantify the frequency of non-21-hydroxylase endocrine causes of neonatal SL in patients diagnosed at our center, describe their clinical, genetic, and laboratory features, review treatment strategies and outcomes, and characterize each disorder individually.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of endocrine-related salt loss, defined by laboratory findings of hyponatremia (serum sodium <130 mEq/L)
  • Age at onset of salt loss between 0 and 60 days of life
  • Patients born between January 1, 1989 and December 31, 2023 and managed at the Experimental Center
  • Obtained Informed consent

排除标准

  • Diagnosis of 21OH ISC

结局指标

主要结局

Measurement of the frequency of the different endocrine causes of salt loss not due to 21-hydroxylase-deficient CAH.

时间窗: at baseline

Percentage of different endocrine causes of salt loss (%)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Baronio

MD

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (1)

Loading locations...

相似试验