Premature Birth, Psychological Stress, Physiological Stress
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESThair 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 methanol for 36 hours, the supernatant portion is extracted, which already contains dissolved cortisol. This solution shall be evaporated to dryness, and then the pellet shall be reconstituted with phosphate (PBS). A commercial kit for the quantification of cortisol by immunoassay (ELISA Victor X5) shall be used. The ELISA kit for the detection of cortisol in saliva (ELISA Kits ' Cortisol ELISA Kits Human Cortisol Competitive ELISA Kit ,Invitrogen).
DIAGNOSTIC_TESTsalivary 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/10 min and the supernatant shall be stored at -20 °C until processing by ELISA kit as per the above protocol.
DIAGNOSTIC_TESTsalivary 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)
DIAGNOSTIC_TESTBayley-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 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.
DIAGNOSTIC_TESTStrange 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 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.
DIAGNOSTIC_TESTParenting 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.
DIAGNOSTIC_TESTPerinatal 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. Moderate Neonatal Risk: 7 to 9 points. 3. High Neonatal Risk: 10 or more points.
DIAGNOSTIC_TESTNeonatal 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 traits. 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. In the second edition of the NBAS a series of 7 supplementary items were added with the intention of better capturing the degree of fragility and the quality of behaviour of high-risk children.
DIAGNOSTIC_TESTGalvanic 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.
DIAGNOSTIC_TESTelectrocardiography (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.
DIAGNOSTIC_TESTBreathing respiratory rate
The transducer is attached to a strap that is placed around the subject's chest, allowing chest movements to be detected during breathing. The strap ensures a secure and comfortable fit for the subject during the measurement process. This transducer is used in conjunction with other BIOPAC components to assess physiological responses. The data obtained from the transducer provides information on respiratory patterns and their relationship to other physiological measures. It will be measured with the BIOPAC MP36R device.
Sponsors
FUNDACIÓN SALUD INFANTIL
Cardenal Herrera University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Children born under 37 weeks of gestation, * Parents of legal age and who have sufficient cognitive capacity to understand the informed consent.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| salivary cortisol (nmol/L) | 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) | 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) | 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) | 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 | Pre-intervention / a year post-intervention | BIOPAC MP36R device |
| breathing rate (breaths per minute) | Pre-intervention / a year post-intervention | BIOPAC MP36R device |
| Parenting Stres Index (PSI) | 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 | 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) | 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 | 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) | 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. |
Countries
Spain
Contacts
Primary ContactJosé Miguel Soria, PhD
Outcome results
None listed