Clinical trial NCT06753435: Co-regulation and Interaction in the NICU
Official title: Development of the Premature Infant's Stress System. Focus on Parent-infant Co-regulation and Interaction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm
Keywords: Preterm infant
Stress system
Family
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Region Östergötland
First posted: 2024-12-31
Enrollment: 105
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born preterm between 30+0 and 34+6 weeks gestational age and their parents \> 18 years old

Brief summary: Preterm infants are exposed to multiple stressors each day, posing a risk of toxic stress that can impact their developing brains during a critical period of sensitivity. Elevated levels of the stress hormone cortisol can impede neuronal connectivity and communication, thereby increasing the likelihood of cognitive impairment and behavioural problems. Synchronized social-emotional mother-infant interaction holds promise in buffering stress reactivity and mitigating long-term stress effects.

Our previous research has shown that preterm infants exhibit higher baseline saliva cortisol levels than full-term infants, along with blunted cortisol reactivity to stressors, irregular cortisol circadian rhythms, and delayed cortisol co-regulation between mother and infant. Another potential stress marker is saliva alpha-amylase (α-amylase), which has garnered increasing interest in adult research. However, there remains a significant gap in the literature concerning saliva α-amylase as a stress marker in preterm infants, warranting further investigation. The overall aim is to study development and relationships between three systems of parent-infant synchrony in preterm infants and their parents and elucidate potential confounding factors for a synchronous correlation. This will be done in relation to standardised care procedures commonly performed in the neonatal intensive care unit.

This observational study will involve 35 families undergoing three video-recorded procedures in the NICU. Saliva will be collected from infants and both parents before and after each procedure so we can analyse co-regulation of cortisol and alpha-amylase. Parent-infant interaction will be analysed from the videos using validated scales.

This study will be the first to document biological co-regulation and social-emotional parent-infant interaction simultaneously involving preterm infants and both parents in the NICU setting. Such insights are pivotal for the future design and implementation of tailored nursing interventions aimed at early stress mitigation, thereby reducing the risk of stress-related consequences.

Detailed description: This observational study adopts a correlational approach to investigate biological co-regulation and parent-infant interaction within families of preterm infants, utilizing a within-family design. Data collection occurs at multiple time points in the NICU, and at 6 and 12 months corrected age. To study parent-infant synchrony and co-regulation with both parents, both should be present and perform three diaper changes in three days. Two will be perforemd by the mother and one by the father. All occassions will be video recorded to study interaction and saliva will be collected before and after the procedure to study co-regulation in cortisol and alpha-amylase during baseline, reactivity and recocvery. At 6 and 12 months parents will respond to questionnaires regarding the child's behavior and development.

Sample size: A power calculation shows sample size of n=28 is sufficient, considering α (two-tailed) = 0.05, β = 0.20, and ICC = 0.5.To consider attrition, we paln to include 35 families.

Eligibility criteria: Inclusion Criteria:

* Swedish- or English-speaking parents aged over 18, born in Europe, and their infants born between gestational weeks 30+0 and 34+6.

Exclusion Criteria:

* Parents with conditions or taking medications affecting the hormone system. Additionally, infants with major malformations or complex care needs that impede interaction possibilities are excluded.

Primary outcomes:
measure: Saliva cortisol correlation (co-regulation) within the triad (mother, father, infant)
timeFrame: GW 32 +/- 2 weeks
measure: Saliva Alpha-amylase correlation (co-regulation) within the triad (mother, father, infant)
timeFrame: GW 32 +/- 2 weeks
measure: Parent-infant emotional availability
timeFrame: GW 32 +/- 2 weeks
measure: Parent-infant synchrony
timeFrame: GW 32 +/- 2 weeks
measure: Parent-infant interaction
timeFrame: GW 32 +/- 2 weeks
Secondary outcomes:
measure: Skin temperature in mother, father and infant
timeFrame: GW 32 +/- 2 weeks
measure: Infant development
timeFrame: 6 and 12 months corrected age, +/-2 months
measure: Infant temperament
timeFrame: 6 and 12 months corrected age, +/-2 months
measure: Communicative Skills and Language Abilities
timeFrame: 12 months corrected age, +/-2 months
Other outcomes:
measure: Parental-to-infant emotional bonding
timeFrame: GW 32 +/- 2 weeks
measure: Parental postpartum depression
timeFrame: GW 32 +/- 2 weeks
measure: Parental well-being
timeFrame: GW 32 +/- 2 weeks
measure: Parental anxiety
timeFrame: GW 32 +/- 2 weeks
measure: Experinces of connection with baby
timeFrame: GW 32 +/- 2 weeks
measure: Parental distress
timeFrame: When the infant is 6 and 12 months +/-2 months
Locations:
city: Linköping
country: Sweden
facility: H.R.H Crown Princess Victoria's Children's and Youth Hospital
Study officials:
References: