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Идёт набор NCT05969431

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

— Наблюдательное Stress, Psychological Father-Child Relations Premature Birth

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: measurement of cortisol level.
Кому может быть актуально
Состояния в реестре: Stress, Psychological, Father-Child Relations, Premature Birth. Базовые параметры: 1 Day — 7 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
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Обзор

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.

Подробное описание

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).

Вмешательства

  • Диагностический тест measurement of cortisol level
    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.

Первичные конечные точки

  • hair cortisol level [Срок оценки: first week after birth, 3 and 6 months after birth]
Вторичные конечные точки (10)
  • Cortisone, testosterone, progesterone, dehydroepiandrosterone level in the paternal hair [Срок оценки: first week after birth, 3 and 6 months after birth]
  • paternal sensitivity [Срок оценки: 6 months after birth]
  • father-child-interaction [Срок оценки: six months of age]
  • paternal depression [Срок оценки: first week, 3 and 6 months after birth]
  • socioeconomic status [Срок оценки: first week after birth]
  • social support [Срок оценки: three months after birth]
  • impact of event scale [Срок оценки: six months after birth]
  • Parental Bonding [Срок оценки: first week, 3 and 6 months after birth]
  • Parental Stress [Срок оценки: six months after birth]
  • Parental Stress [Срок оценки: first week, 3 and 6 months after birth]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • University Hospital of Cologne — Cologne

Идентификаторы

NCT: NCT05969431 · 23-114058

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗