Actively Recruiting
Co-regulation and Interaction in the NICU
Led by Linkoeping University · Updated on 2025-03-07
105
Participants Needed
1
Research Sites
359 weeks
Total Duration
On this page
Sponsors
L
Linkoeping University
Lead Sponsor
R
Region Östergötland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Co-regulation and Interaction in the NICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents must speak Swedish or English
- Parents must be over 18 years old
- Parents must be born in Europe
- Infants must be born between gestational weeks 30+0 and 34+6
You will not qualify if you...
- Parents with conditions or medications affecting the hormone system
- Infants with major malformations
- Infants needing complex care that limits interaction possibilities
AI-Screening
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Trial Site Locations
Total: 1 location
1
H.R.H Crown Princess Victoria's Children's and Youth Hospital
Linköping, Sweden, 58185
Actively Recruiting
Research Team
E
Evalotte Mörelius, PhD, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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