Clinical trial Recruiting at 1 site Observational Ages 2 Days and up

Investigating parent-infant interactions in preterm infants

Official title: Development of the Premature Infant's Stress System. Focus on Parent-infant Co-regulation and Interaction

Run by Linkoeping University · NCT06753435 · Data updated 2026-11-12

This study looks at how parents and their preterm babies interact in the NICU to see if these connections can help reduce stress and support the babies' growth and development.

Quick facts

Study typeObservational
Ages2 Days and up
SexAll
Enrollment105 (estimated)
SponsorLinkoeping University
Government
Locations1 site (Linköping)
StatusRecruiting
StartedJanuary 7, 2025
Main results expectedDecember 31, 2027
Study endsDecember 2031
Registry record updatedMarch 7, 2025
Trial IDNCT06753435 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include Swedish- or English-speaking parents over 18 with infants born between gestational weeks 30+0 and 34+6.

Probably not a fit

Patients with major malformations or complex care needs that impede interaction, as well as parents with conditions affecting the hormone system, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study explores the biological co-regulation and interaction between parents and their preterm infants in the NICU. It employs a within-family design, collecting data at multiple time points, including video recordings of diaper changes and saliva samples to measure cortisol and alpha-amylase levels. Parents will also complete questionnaires regarding their child's behavior and development at 6 and 12 months corrected age. The aim is to understand how synchronized interactions can buffer stress and support healthy development in preterm infants.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for supporting the emotional and developmental needs of preterm infants and their families.

How similar studies have gone: While the specific approach of measuring saliva alpha-amylase in this context is novel, previous studies have shown that parent-infant interaction can positively influence stress regulation in infants.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • H.R.H Crown Princess Victoria's Children's and Youth Hospital
    Linköping, Sweden
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.