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临床试验/NCT07358845
NCT07358845已完成不适用

Hematological Profiles of Preterm Infants: Can it be Effected by Antenatal Steroids?

Princess Anna Mazowiecka Hospital, Warsaw, Poland0 个研究点目标入组 1,048 人开始时间: 2011年1月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,048

研究概览

简要总结

The goal of this observational study is to investigate the impact of antenatal corticosteroids (ANS) administration on haematological parameters in premature infants born to women exposed to ANS.

The primary objective is to assess whether ANS administration in pregnant women during pregnancy alters haematological parameters in preterm neonates; The secondary objectives are: (1) to evaluate changes in haematological parameters in preterm infants in relation to the time interval between ANS administration and delivery, and (2) to assess alterations in haematological parameters according to different maternal ANS dosage regimens.

A total of 524 mother-infant pairs were included in the study. Participants were allocated into six groups based on the time interval between antenatal corticosteroid administration and delivery.

详细描述

Antenatal corticosteroids (ANS) have been widely used since 1972, when Liggins and Howie first demonstrated their beneficial effects on neonatal outcomes. Over time, the recognized benefits of ANS have extended beyond neonatal respiratory support in preterm infants. Current international guidelines recommend administering ANS to pregnant women at risk of imminent preterm delivery before 34 weeks of gestation. ANS therapy has been shown to reduce both morbidity and mortality among preterm neonates.

Glucocorticoid exposure promotes the maturation of multiple fetal organ systems, with a primary emphasis on accelerating lung development and reducing the risk of respiratory distress syndrome (RDS). The optimal therapeutic effect of ANS is observed within a window of 24 hours to 7 days following administration.

However, the potential adverse effects of corticosteroid therapy should not be overlooked and warrant careful consideration. First, corticosteroids may have negative effects on the developing brain, potentially leading to psychosomatic and neurodevelopmental disturbances, owing to the high density of glucocorticoid receptors in brain regions involved in behavioral regulation and endocrine control. Second, several studies have suggested that ANS may increase the risk of neonatal hypoglycemia and disrupt thyroid hormone homeostasis.

In addition, a study conducted by Romejko et al. demonstrated that ANS administration is associated with alterations in hematological parameters among women exposed to prenatal steroids.

Considering that anemia is a common condition among preterm infants, it is crucial to analyze additional factors that may influence hematological test results and complicate diagnostic evaluation. Therefore, reliable assessment of hematological parameters at birth is particularly important in this population.

研究设计

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

入排标准

年龄范围
0 Days 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age 24 weeks - <36 weeks

排除标准

  • gestational age <24 and⩾36
  • major congenital or chromosomal abnormalities
  • intrauterine foetal demise
  • women with active or suspected cancer
  • women underwent surgery or chemotherapy during pregnancy
  • women whose pregnancy was prematurely terminated due to maternal indications
  • women who received ANS outside of our hospital
  • lack of parental consent.

研究者

发起方
Princess Anna Mazowiecka Hospital, Warsaw, Poland
申办方类型
Other
责任方
Sponsor

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