Parental Stress and Attachment in Preterm Infants

Официальное название

Parental Stress and Attachment in Premature Infants in Their First Months of Life in Early Months of Life in Child Development and Early Care Centres.

Обзор

Introduction: Advances in neonatology mean a significant reduction in mortality in premature infants as well as an increase in the risk of morbidity in the medium, short and long term. Furthermore, previous studies have linked prematurity, as an associated risk factor, with possible alterations in the bonding between the child and his or her mother in the first years of life. The possible impact that the stay in the neonatal unit may have on the mental health of the parents is noted. In fact, several studies have shown that the hospital environment of neonatal units may contribute to increased stress and anxiety in mothers. On the other hand, prematurity is one of the causes of referral to Child Development and Early Care Centres, to address their development in the first years of life, as well as for family support. One of the functions of early childhood professionals is to guarantee the development of a secure attachment between the child and his or her caregivers. Little is known about whether maternal stress levels can influence mother-child interactions and thus influence the attachment relationship in the early years of life. Objective: to analyse the association between mothers' stress level due to preterm birth and attendance at a Child Development and Early Care Centre and child development and patterns of mother-child interactions.

Вмешательства

• Диагностический тест hair cortisol
  To extract cortisol from the hair, the sample is carefully sectioned into segment lengths that will approximate the time period of interest (from the outermost part, if the hair is 3 cm long, the cortisol secreted proportionally by the individual in the last 3 months of life will be extracted). Then, an approximate average weight per sample of 150 mg will be selected. The samples will be individualised and placed in eppendorfs (one for each patient) and sprayed with scissors. After incubation in
• Диагностический тест salivary cortisol
  Three saliva samples will be collected from each subject, at 8:00, 15:00 and 23:00 hours. Before collecting the saliva they will be instructed to rinse their mouth with cold water, without brushing their teeth. They should also not eat or drink in the hour before the sample is taken. Approximately 1 ml of saliva, collected by direct expectoration into an ependymal tube, shall be obtained and the samples shall be stored for 24 hours at 4°C . Subsequently, samples shall be centrifuged at 2 500 rpm
• Диагностический тест salivary Oxytocin
  The treatment and collection of saliva as a biological sample shall be identical to the protocol described for the determination of cortisol. The determination of oxytocin shall be carried out by the use of ELISA kit for immunoassay (Oxytocin ELISA Kit (ab133050 ABCAM)
• Диагностический тест Bayley-III Child Development Assessment Scales
  They are a set of three standardised assessment scales, which assess the cognitive, motor and language development of children aged 1 and 42 months. For our study, we will use only the motor scale, which is composed of two subscales, the gross motor scale and the fine motor scale. This motor scale is composed of 138 items (the gross motor scale is composed of 72 items and the fine motor scale of 66 items) which assess the degree of control of the body, the coordination of large muscle masses and
• Диагностический тест Strange Situation
  The Strange Situation is a standardised observational procedure in which the child is exposed to two moments of separation from his/her attachment figure, two moments of reunion with the attachment figure and moments in which he/she interacts with an unknown person, specifically 8 episodes (lasting 3 minutes) in which the level of stress provoked in the child increases in intensity as the situation progresses. It is estimated to last around 20 minutes. It is assessed on a 7-point Likert-type sca
• Диагностический тест Parenting Stress Index (PSI)
  It assesses the stress experienced in parenting through several subscales such as parental distress, dysfunctional parent-child interaction and whether the child is a difficult child based on how parents perceive their children's behaviour.
• Диагностический тест Perinatal Risk Inventory
  \- The Perinatal Risk Inventory is a measuring instrument that provides information on the neonatal situation prior to discharge and facilitates an estimate of the biological risk that the child may present from a very early age. The factors that are analysed in this inventory are evaluated with a score from 0 to 3 for each of the factors mentioned above, ranging from a minimum of 0 points to a maximum of 51. The levels of risk were determined as follows: 1. Low Neonatal Risk: 0 to 6 points. 2.
• Диагностический тест Neonatal Behavioural Assessment (NBAS)
  is an assessment technique that provides a profile of scores that allows us to detect a possible alteration or pathology, but at the same time, within normal parameters, to detect both the potential or 'strong points' and the problems or 'weak points' of the newborn, as well as their peculiar ways of acting and reacting to environmental variables. Therefore, a profile of the child's behavioural characteristics is obtained, which can be considered as a first outline of the child's temperamental t
• Диагностический тест Galvanic Response
  Galvanic Response: has the function of measuring the galvanic response of the skin, also known as electrodermal activity (EDA). It is used to record the electrical behaviour of the skin, which varies according to the activity of the sweat glands. This measurement of electrodermal activity is essential for studying the activity of the autonomic nervous system, which controls involuntary body functions such as sweating and heart rate. It will be measured with the BIOPAC MP36R device.
• Диагностический тест electrocardiography (ECG)
  ECG is used as a monitoring target for various cardiovascular conditions. It will be measured with the BIOPAC MP36R device. P, Q, R, S, T, U waves; QRS complex, PR interval and QT interval and PR segment and ST segment.

Первичные конечные точки

• salivary cortisol (nmol/L) [Срок оценки: Pre-intervention / a year post-intervention]
• hair cortisol (nmol/L) [Срок оценки: Pre-intervention / a year post-intervention]
• salivary oxytocin (units/ml) [Срок оценки: Pre-intervention / a year post-intervention]
• electrocardiography (mV) [Срок оценки: Pre-intervention / a year post-intervention]
• galvanic response by means of Skin conductance (SC) micro-siemens or micro-omhios [Срок оценки: Pre-intervention / a year post-intervention]
• breathing rate (breaths per minute) [Срок оценки: Pre-intervention / a year post-intervention]
• Parenting Stres Index (PSI) [Срок оценки: Pre-intervention / a year post-intervention]
• Perinatal Risk Inventory [Срок оценки: Pre-intervention / a year post-intervention]
• Neonatal Behavioural Assessment (NBAS) [Срок оценки: Pre-intervention / a year post-intervention]
• Bayley-III Child Development Assessment Scales [Срок оценки: Pre-intervention / a year post-intervention]

Критерии участия

Критерии включения

• Children born under 37 weeks of gestation,
• Parents of legal age and who have sufficient cognitive capacity to understand the informed consent.

Критерии исключения

\-

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 1 центр

• Universidad CEU Cardenal Herrera, plaza Reyes Catolico 19, 03204 Elche (alicante ) — Elche

Идентификаторы

NCT: NCT06813560 · CEEI24/544

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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