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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

December 20, 2024

Completed

1 month until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed

6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed

Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

December 20, 2024

Last Update Submit

February 3, 2025

Conditions

Premature Birth Psychological Stress Physiological Stress

Outcome Measures

Primary Outcomes (11)

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)
Pre-intervention / a year post-intervention
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)
Pre-intervention / a year post-intervention
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)
Pre-intervention / a year post-intervention
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
Pre-intervention / a year post-intervention
galvanic response by means of Skin conductance (SC) micro-siemens or micro-omhios
BIOPAC MP36R device
Pre-intervention / a year post-intervention
breathing rate (breaths per minute)
BIOPAC MP36R device
Pre-intervention / a year post-intervention
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.
Pre-intervention / a year post-intervention
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.
Pre-intervention / a year post-intervention
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.
Pre-intervention / a year post-intervention
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
Pre-intervention / a year post-intervention
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.
Pre-intervention / a year post-intervention

Study Arms (2)

Premature mothers

mothers who have given birth before 37 weeks' gestation

Diagnostic Test: hair cortisolDiagnostic Test: salivary cortisolDiagnostic Test: salivary OxytocinDiagnostic Test: Bayley-III Child Development Assessment ScalesDiagnostic Test: Strange SituationDiagnostic Test: Parenting Stress Index (PSI)Diagnostic Test: Perinatal Risk InventoryDiagnostic Test: Neonatal Behavioural Assessment (NBAS)Diagnostic Test: Galvanic ResponseDiagnostic Test: electrocardiography (ECG)Diagnostic Test: Breathing respiratory rate

mothers with full-term births (control group)

mothers who have given birth after 37 weeks gestation

Interventions

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).