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

Sponsor
University of Cologne
Study ID
NCT05969431
Status
Recruiting
Apply to this trial

Conditions

  • Father-Child Relations
  • Premature Birth
  • Stress, Psychological

Eligibility Criteria

Sex
ALL
Age
1 Day - 7 Days
Healthy Volunteers
Accepted

Interventions

  • measurement of cortisol level — DIAGNOSTIC_TEST
    We will measure the cortisol level from the hair sample of the father at three time points. Furthermore the father will answer questionnaires at three time points and the paternal sensitivity is measured once.

Study Details

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.

Key Dates

First listed
Aug 1, 2023
Start date
Oct 1, 2024
Status verified
Nov 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: fathers of mature infants
    Fathers of newborns' above 37 weeks of gestation
  • Arm: fathers of moderate and late preterm infants
    Fathers of moderate and late preterm infants, i.e. gestational age from 32 0/7 to 36 6/7 weeks of gestation.
  • Arm: fathers of very low birth weight preterm infants
    Fathers of very low birth weight preterm infants, i.e. gestational age from 22 0/7 to 31 6/7 weeks of gestation and with a birth weight below 1500 g.

Primary Outcome Measure

hair cortisol level [ Time Frame: first week after birth, 3 and 6 months after birth ]

Central Contacts

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