跳至主要内容
临床试验/CTRI/2021/01/030457
CTRI/2021/01/030457尚未招募不适用

A retrospective observational study of cord blood procalcitonin as a routine screening tool for the diagnosis of early onset neonatal sepsis in neonates born to mothers after assisted fertility

Gunasheela Surgical and Maternity Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年1月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Usefulness of procalcitonin in Assisted Reproductive Treatment in babies

研究概览

简要总结

Early onset neonatal sepsis (EONS) has been a major cause of morbidity and mortality in neonates , the clinical signs of early-onset neonatal sepsis (EONS) are nonspecific, sometimes late to develop, and indistinguishable from those of noninfectious disorders. The early diagnosis of EONS is difficult but is essential to improve outcomes. Early onset neonatal sepsis must be diagnosed while the patient is still asymptomatic. Such a diagnosis would rest on the identification of NBs at risk of early-onset sepsis.

Neonates born to mothers who are treated for infertility have an increased risk of preterm delivery, multiple pregnancies, and premature rupture of membranes (PROM). Each one of them individually is a risk factor for neonatal sepsis

In our assisted fertility center, we have observed a similar pattern, and few cases resulted in EONS without risk factors.  Blood culture is the gold standard for the diagnosis of neonatal sepsis but takes a long time. Clinical diagnosis is difficult and rather late to appear.

Biochemical  markerslike Neutropenia, Thrombocytopenia, Immature neutrophils (Band cells + myelocytes + metamyelocytes) to total neutrophils ratio (l/T) > 0.20,  C-reactive protein(CRP), neonatal procalcitonin, Interleukin (IL) 6 & IL 8, serum amyloid A, Tumor necrosis Factor (TNF) α have their own limitations and some more are in evaluative phase

Procalcitonin (PCT) is a prohormone secreted by most parenchymal tissues. Recent studies demonstrate that cord blood PCT levels could be used to discriminate between septic and nonseptic neonates at an early stage. The derived cutoff values of PCT used in the cord blood studies ranged from 0.5 to 1.22ng/mL.

Operating curves of PCT determined 0.6 ng/ml as the best cut-off (immunoâ€chromatographic semiquantitative test). The sensitivity, specificity, and negative and positive predictive values were respectively 87.5%, 98.7%, 87.5%, and 98.7% for PCT.  It also presents good positive and negative likelihood ratios and appears to be more reliable than CRP. We have planned a retrospective observational study of the cord blood procalcitonin to use this as a screening tool in diagnosis of EONS.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 7.00 Day(s)(—)
性别
All

入选标准

  • All babies born to mothers who had assisted reproduction in Gunasheela surgical and maternity hospital, and all babies born to mothers who conceived spontaneously and delivered in Gunasheela surgical and maternity hospital.

排除标准

  • Major congenital anomalies, Patient transfer to another hospital.

结局指标

主要结局

Usefulness of procalcitonin in Assisted Reproductive Treatment in babies

时间窗: December 2019 to April 2020

次要结局

  • Usefulness of procalcitonin in spontaneous pregnancies(December 2019 to April 2020)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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