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

U

University of Cologne

Status

Enrolling

Conditions

Stress, Psychological
Father-Child Relations
Premature Birth

Treatments

Diagnostic Test: measurement of cortisol level

Study type

Observational

Funder types

Other

Identifiers

NCT05969431
23-114058

Details and patient eligibility

About

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.

Full description

For expectant parents, the birth of a child is often a stressful situation. In the case of a premature birth, the psychological stress is usually increased because the parents frequently could not prepare for the birth. Therefore, the researcher would like to investigate this stress of fathers of newborn children.

For this purpose, the stress hormone cortisol in the fathers' hair will be analysed and questionnaires on the fathers' mental health will be collected. Subsequently, the differences between fathers of prematurely born and of maturely born children will be compared.

The investigators will do the analyses at three time points: the first time point will be at the first week after birth, the second three months and the third six months after birth. At six months of the infant's age, additionally the paternal sensitivity will be measured.

The compared groups will differ with respect to gestational age: Group 1 includes preterm infants with a gestational age below 32 weeks and a birth weight <1500 grams (very low birthweight infants), group 2 preterm infants with a gestational age between 32 0/7 to 36 6/7 (moderate and late preterm infants) and group 3 consists of mature infants (over 37 weeks gestational age).

Enrollment

120 estimated patients

Sex

All

Ages

1 to 7 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Premature or mature infant (22 0/7 to 42 0/7 weeks of gestation)
  • For mature infants (37 0/7 to 42 0/7 weeks of gestation) undisturbed neonatal period
  • No severe malformations or genetic diseases of the newborn child
  • Sufficient knowledge of German of the father
  • written consent of the custodial parents

Exclusion criteria

  • adoptive or foster paternity
  • hair length below 3 cm at the posterior vertex region of the back of the father's head
  • endocrine disorders, especially of the adrenocortical system (e.g. Cushing syndrome, adrenal insufficiency)
  • taking steroidal medications or other drugs that affect the activity of the hypothalamic-pituitary-adrenocortical system
  • paternal psychological or severe physical illness

Trial design

120 participants in 3 patient groups

fathers of mature infants
Description:
Fathers of newborns' above 37 weeks of gestation
Treatment:
Diagnostic Test: measurement of cortisol level
fathers of moderate and late preterm infants
Description:
Fathers of moderate and late preterm infants, i.e. gestational age from 32 0/7 to 36 6/7 weeks of gestation.
Treatment:
Diagnostic Test: measurement of cortisol level
fathers of very low birth weight preterm infants
Description:
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.
Treatment:
Diagnostic Test: measurement of cortisol level

Trial contacts and locations

1

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Central trial contact

Eva Heine, Dr. med.; Katrin Mehler, PD Dr.

Data sourced from clinicaltrials.gov

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