Parental Stress and Attachment in Preterm Infants

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• Women only
• Healthy volunteers accepted
• Adult, Older adult

Study population: Children admitted to the Neonatal Unit and who start treatment at the Child Development and Early Care Centre of the Fundación Salud Infantil de Elche (Alicante, Spain).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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.

Conditions

Premature Birth, Psychological Stress, Physiological Stress

Being tested

hair cortisol, salivary cortisol, salivary Oxytocin, Bayley-III Child Development Assessment Scales, Strange Situation

Medical subject headings

Premature Birth, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• hair cortisolDiagnostic test

  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).

• salivary cortisolDiagnostic test

  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.

• salivary OxytocinDiagnostic test

  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)

• Bayley-III Child Development Assessment ScalesDiagnostic test

  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.

• Strange SituationDiagnostic test

  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.

• Parenting Stress Index (PSI)Diagnostic test

  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.

• Perinatal Risk InventoryDiagnostic test

  • 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.

• Neonatal Behavioural Assessment (NBAS)Diagnostic test

  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.

• Galvanic ResponseDiagnostic test

  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.

• electrocardiography (ECG)Diagnostic test

  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.

• Breathing respiratory rateDiagnostic test

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. salivary cortisol (nmol/L)

   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)

   Measured: Pre-intervention / a year post-intervention

2. hair cortisol (nmol/L)

   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)

   Measured: Pre-intervention / a year post-intervention

3. salivary oxytocin (units/ml)

   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)

   Measured: Pre-intervention / a year post-intervention

4. electrocardiography (mV)

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

   Measured: Pre-intervention / a year post-intervention

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

   BIOPAC MP36R device

   Measured: Pre-intervention / a year post-intervention

6. breathing rate (breaths per minute)

   BIOPAC MP36R device

   Measured: Pre-intervention / a year post-intervention

7. Parenting Stres Index (PSI)

   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.

   Measured: Pre-intervention / a year post-intervention

8. Perinatal Risk Inventory

   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.

   Measured: Pre-intervention / a year post-intervention

9. Neonatal Behavioural Assessment (NBAS)

   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.

   Measured: Pre-intervention / a year post-intervention

10. Bayley-III Child Development Assessment Scales

    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

    Measured: Pre-intervention / a year post-intervention

11. Ainsworth's test (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 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.

    Measured: Pre-intervention / a year post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted7 Feb 2025
2. Study start1 Feb 2025 (estimated)
3. Primary completion1 Apr 2025 (estimated)
4. Study completion1 Aug 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Premature BirthStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.