Clinical trial NCT06813560: Parental Stress and Attachment in Preterm Infants
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premature Birth
Psychological Stress
Physiological Stress
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: FUNDACIÓN SALUD INFANTIL
First posted: 2025-02-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: salivary cortisol (nmol/L)
timeFrame: Pre-intervention / a year post-intervention
measure: hair cortisol (nmol/L)
timeFrame: Pre-intervention / a year post-intervention
measure: salivary oxytocin (units/ml)
timeFrame: Pre-intervention / a year post-intervention
measure: electrocardiography (mV)
timeFrame: Pre-intervention / a year post-intervention
measure: galvanic response by means of Skin conductance (SC) micro-siemens or micro-omhios
timeFrame: Pre-intervention / a year post-intervention
measure: breathing rate (breaths per minute)
timeFrame: Pre-intervention / a year post-intervention
measure: Parenting Stres Index (PSI)
timeFrame: Pre-intervention / a year post-intervention
measure: Perinatal Risk Inventory
timeFrame: Pre-intervention / a year post-intervention
measure: Neonatal Behavioural Assessment (NBAS)
timeFrame: Pre-intervention / a year post-intervention
measure: Bayley-III Child Development Assessment Scales
timeFrame: Pre-intervention / a year post-intervention
measure: Ainsworth's test (Strange Situation)
timeFrame: Pre-intervention / a year post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Universidad CEU Cardenal Herrera, plaza Reyes Catolico 19, 03204 Elche (alicante )
state: Alicante
Study officials:
References: