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临床试验/NCT06337136
NCT06337136招募中不适用

Neonatal Motor Pattern automatIc Analysis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
comparison of the computer score with the clinical examination

研究概览

简要总结

This project consists in developing a computerized clinical assessment system for newborns that takes into account the four major criteria of the various clinical scales: facial mimicry, cry, posture and movement. Classification of motor patterns according to gestational age at birth The aim of this work is the automated identification of pathological motor patterns related to anoxo-ischemic encephalopathy/brachial plexus paralysis/early neonatal bacterial infection/stroke/etc ...

详细描述

Neonatal Care and Newborn Examination:

Every newborn undergoes a comprehensive clinical examination in the delivery room before being transferred to the postpartum ward with their mother (decree of October 18, 1994). At least one additional full examination is conducted during the maternity stay. Mandatory before the 8th day of life, this examination is recorded in the health booklet and allows for the issuance of the first health certificate (8th day certificate). It is performed in the presence of the mother or both parents, in a well-lit, adequately heated room, preferably before a meal or during a care routine, when the child is alert, and following hygiene rules (handwashing, use of a dedicated gown for the newborn, and disinfection of equipment). Significant clinical variations are possible among newborns, and a number of minor anomalies may be detected.

The neurological assessment of the newborn begins with gathering maximum information about prenatal history and birth context. Family and social backgrounds are also crucial. For instance, previous neonatal deaths in the family may indicate autosomal recessive metabolic disorders, while details of any previous maternal miscarriage are particularly relevant in suspected X-linked dominant disorders, where male lethality is common. Medical records are extremely useful sources for Apgar scores, blood gas results, antepartum monitoring data, and any obstetric complications. Clinical information regarding the immediate postpartum period, known as the "golden hour" in high-risk groups, can also be very valuable. Additionally, nurse observations, when available, are generally invaluable. When evaluating newborns with paroxysmal disorders, video sequences of the events in question can provide valuable diagnostic clues.

Clinical examination remains a central element and perhaps the most cost-effective and safest tool for evaluating newborns suspected of having a neurological problem ("Wusthoff CJ. How to use: the neonatal neurological examination. Arch Dis Child Educ Pract Ed. 2013;98:148-53." Extract from: Mustafa A. M. Salih. "Clinical Child Neurology." iBooks.). Thus, the main objectives of the examination are to determine whether the newborn is "neurologically normal" or not and to initiate further investigations if necessary. It also serves to assess the worsening (or improvement) of the newborn's condition over time. It should be noted that the newborn's neurological status often cannot be fully determined by a single neurological examination, especially if it is performed quite early. In fact, the predictive value of the neurological examination tends to improve with the newborn's chronological age, as illustrated by the case of a newborn who suffered significant hypoxic-ischemic injury at birth, for example. Indeed, this child's clinical presentation will vary over time, and a complete and accurate assessment of lesions is often possible remotely. Furthermore, it is well known that the newborn's neurological status can be affected by a range of "non-neurological" factors such as medications administered to the mother during pregnancy, infections, respiratory disorders, and unpleasant stimuli such as pain (from the cold hand of an examiner, for example) and hunger.

Description of the Research Focus There are several standardized and validated scales and approaches widely used in various neonatal units. Each has its strengths and weaknesses, but they are all comprehensive enough to provide an idea of the neurodevelopmental profile of both full-term and premature newborns. Many of them, such as the Dubowitz examination, are freely accessible on the internet and in most neonatology manuals.

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
1 Day 至 15 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Hospitalized newborn in the maternity ward or in the neonatal ICU at Raymond Poincaré hospital or Poissy-Saint-Germain hospital.
  • Newborn with 37 weeks of gestation.
  • Agreement of legal guardians / non - opposition.

排除标准

  • Refusal of legal guardians.
  • Minor parents.

结局指标

主要结局

comparison of the computer score with the clinical examination

时间窗: 3 years

comparison of the computer score with the clinical examination

次要结局

  • Comparison of the evolution of neurological examination and posture based on the day of life for each patient and each group of patients(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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