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Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated November 27, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
  2. Primary completion date: Oct 31, 2024 to Jun 30, 2025
    • Start date: Jan 1, 2024 to Oct 1, 2024
    • Study completion date: Apr 28, 2025 to Dec 31, 2025
    • Secondary endpoints: 7 to 10
    v5
  3. Start date: Oct 1, 2023 to Jan 1, 2024v4
  4. Start date: Aug 1, 2023 to Oct 1, 2023
    • Primary completion date: Aug 31, 2024 to Oct 31, 2024
    • Study completion date: Feb 28, 2025 to Apr 28, 2025
    v3
  5. Study description expanded, about 5 wordsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to compare the paternal hair cortisol as a marker for chronic stress in prematurely born children to maturely born children. The main questions it aims to answer are: * How differ the cortisol level between groups? * How change the cortisol level over time? * Are there secondary outcomes associated to the cortisol level of fathers? Participants will give a hair sample to analyse the cortisol level and fill out questionnaires at three time points. At six months of the infant's age, the investigators will also measure the paternal sensitivity.
Trial Details
NCT Number NCT05969431
Lead Sponsor University of Cologne
Collaborators: University of Siegen
Conditions
(from sponsor)		 Stress, Psychological, Father-Child Relations, Premature Birth
Related terms Premature Birth, Stress, Psychological
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov