Actively Recruiting

Age: 2Days +
All Genders
Healthy Volunteers
NCT06753435

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

Age: 2Days +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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