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临床试验/NCT07329192
NCT07329192招募中不适用

First Required Medical Examination of the Newborn After Discharge From the Maternity Hospital: Does the Choice of a General Practitioner Facilitate Its Completion Within the Recommended Timeframe ?

Centre Hospitalier Sud Francilien1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年1月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Timely completion of the newborn's first post-discharge medical examination

研究概览

简要总结

The goal of this observational study is to determine whether, in a population of well-informed parents, choosing a general practitioner at the maternity hospital facilitates the completion of the newborn's first required medical examination within the second week of life.

The main question it aims to answer is: Does selecting a general practitioner before leaving the maternity hospital allow the newborn's first medical examination to be completed within the recommended period?

Participants will be asked to complete an initial questionnaire, which will be given to them before leaving the maternity hospital, and then a second questionnaire by telephone one month later.

详细描述

For eligible newborns, an information sheet will be provided to the parents or legal guardians.

Parents or legal guardians who have been informed of the study and do not object to their child's participation will receive a questionnaire between the second postnatal day (D2) and discharge from the maternity ward.

Each completed questionnaire will be collected prior to discharge. The research team will then contact the parents by telephone on day 30 (±3 days) to administer the second questionnaire and record their responses.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Term newborn ≥ 37 weeks of gestation
  • Birth weight > 3000 g
  • Growth > 5th percentile according to Fenton curves
  • No diagnosed or suspected pathology during antenatal care or the maternity stay
  • No postnatal complications requiring temporary hospitalization in the neonatal unit or kangaroo care unit

排除标准

  • Pathology diagnosed or suspected in the newborn during the maternity hospital stay.
  • Requirement for temporary hospitalization in a neonatal unit or kangaroo care unit, including but not limited to: neonatal jaundice, abnormal oxygenation or laboratory findings, suspected early-onset bacterial infection, transient respiratory distress requiring more than 2 hours of non-invasive ventilation at birth, monitoring of mother-infant bonding, or maternal treatments during pregnancy necessitating clinical monitoring.
  • Language barrier in both parents.
  • Parents (legal guardians) informed of the study and having declined participation for themselves and their child.

研究组 & 干预措施

newborn

newborn

干预措施: Advance Selection of a General Practitioner (Other)

结局指标

主要结局

Timely completion of the newborn's first post-discharge medical examination

时间窗: at 1 month

Assessment of whether the newborn's first medical examination after discharge from the maternity hospital is performed within the recommended period (second week of life, between day 8 and day 15). The outcome is measured as a binary variable: completed within the recommended period / not completed within the recommended period.

次要结局

  • Sociodemographic data of the parents' choice of physician for the newborn's first consultation(at day 0)
  • Questions regarding the first post-hospitalization consultation(at maternity (assessed up to day 7))
  • Concordance between the physician designated in maternity and the physician who performed the consultation(at 1 month)
  • Factors associated with delayed completion of the newborn's first consultation(at 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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