跳至主要内容
临床试验/NCT06813560
NCT06813560尚未招募不适用

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.

Cardenal Herrera University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
salivary cortisol (nmol/L)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

salivary cortisol (nmol/L)

时间窗: Pre-intervention / a year post-intervention

ELISA Kits ' Cortisol ELISA Kits Human Cortisol Competitive ELISA Kit ,Invitrogen. Quantification of cortisol and oxytocin: RT-2100C microplate reader, which is a general-purpose microprocessor-controlled photometric system designed to read and calculate biomarker assay results (optic ivymen system)

hair cortisol (nmol/L)

时间窗: Pre-intervention / a year post-intervention

ELISA Kits ' Cortisol ELISA Kits Human Cortisol Competitive ELISA Kit ,Invitrogen. Quantification of cortisol and oxytocin: RT-2100C microplate reader, which is a general-purpose microprocessor-controlled photometric system designed to read and calculate biomarker assay results (optic ivymen system)

salivary oxytocin (units/ml)

时间窗: Pre-intervention / a year post-intervention

ELISA Kits ' Cortisol ELISA Kits Human Cortisol Competitive ELISA Kit ,Invitrogen. Quantification of cortisol and oxytocin: RT-2100C microplate reader, which is a general-purpose microprocessor-controlled photometric system designed to read and calculate biomarker assay results (optic ivymen system)

electrocardiography (mV)

时间窗: Pre-intervention / a year post-intervention

BIOPAC MP36R device: ECG: P, Q, R, S, T, U waves; QRS complex, PR interval and QT interval and PR segment and ST segment

galvanic response by means of Skin conductance (SC) micro-siemens or micro-omhios

时间窗: Pre-intervention / a year post-intervention

BIOPAC MP36R device

breathing rate (breaths per minute)

时间窗: Pre-intervention / a year post-intervention

BIOPAC MP36R device

Parenting Stres Index (PSI)

时间窗: Pre-intervention / a year post-intervention

PSI-SF is a 36-item, self-report measure of parenting stress. It includes three subscales: Parental Distress (PD; e.g, "I feel trapped by my responsibilities as a parent", "I feel lonely and without friends"), Parent-Child Dysfunctional Interaction (PCDI; e.g, "Sometimes I feel my child doesn't like me and doesn't want to be close to me", "When I do things for my child I get the feeling that my efforts are not appreciated" ), and Difficult Child (DC; e.g, "My child makes more demands on me than most children", "My child gets upset easily over the smallest thing"). Each subscale consists of 12 items rated from 1 (strongly disagree) to 5 (strongly agree), with subscales scores ranging from 12 to 60. A Total score is calculated by summing the three subscales scores, ranging from 36 to 180. Scores of 90 or above may indicate a clinical level of stress. Cronbach's alpha coefficients of .91 for PSI-SF total score, and .87, .80, and .85 for PD, PCDI, and DC subscales.

Perinatal Risk Inventory

时间窗: Pre-intervention / a year post-intervention

It consists of a total of 18 risk factors such as 1) Apgar score; 2) electro-encephalogram; 3) non-metabolic seizures; 4) intraventricular haemorrhage; 5) hydrocephalus; 6) neurological findings (not for hydrocephalus or HIV); 7) gestational age at birth; 8) weight for gestational age; 9) dysmorphias; 10) assisted ventilation; 11) cranial growth (children hospitalised 6 or more weeks); 12) cranial growth (children hospitalised less than 3 weeks); 13) polycythaemia; 14) meningitis; 15) hypoglycaemia; 16) congenital infections; 17) hyperbilirubinaemia; and 18) associated medical problems (not central nervous system). These factors are assessed with a score from 0 to 3 for each of the above factors, ranging from a minimum of 0 points to a maximum of 51 points. Risk levels: 1. Low Neonatal Risk: 0 to 6 points. 2. Moderate Neonatal Risk: 7 to 9 points. 3. High Neonatal Risk: 10 or more points.

Neonatal Behavioural Assessment (NBAS)

时间窗: Pre-intervention / a year post-intervention

It evaluates the behavioural repertoire of the newborn in 28 behavioural items that are assessed according to a 9-point scale. The scale also includes an assessment of neurological status in 18 reflex items, each with a 4-point rating. The NBAS can be used without any adaptations for full-term children and can be used until the end of the second month of life. With the addition of supplementary items it can also be used with apparently healthy preterm infants (less than 37 weeks gestation) and for them, depending on the degree of immaturity, application is possible up to 48 weeks post-conceptional age. \<7 points: low, suggests newborn distress requiring intervention. 7-9 points: normal. child in good health.

Bayley-III Child Development Assessment Scales

时间窗: Pre-intervention / a year post-intervention

They are a set of three standardised assessment scales, which evaluate the cognitive, motor and language development of children aged 1 and 42 months. 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 the manipulative ability of hands and fingers. The total administration time of the motor area for 12-month-old children, as in the case of the sample, is between 15 and 20 minutes. average motor score: 100; \<85=mild impairment; \<70=moderate-severe impairment

Ainsworth's test (Strange Situation)

时间窗: Pre-intervention / a year post-intervention

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 scale, so that low scores indicate low frequency and intensity of the behaviour. These responses allow us to identify three types of attachment: secure attachment, insecure-avoidant attachment and insecure-ambivalent attachment. The strange situation only allows us to assess attachment in children between 1 and 2 years of age.

次要结局

未报告次要终点

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Miguel Soria Lopez

Clinical Professor

Cardenal Herrera University

研究点 (1)

Loading locations...

相似试验