Investigating parent-infant interactions in preterm infants
Development of the Premature Infant's Stress System. Focus on Parent-infant Co-regulation and Interaction
Linkoeping University · NCT06753435
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 type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 2 Days and up |
| Sex | All |
| Sponsor | Linkoeping University (other gov) |
| Locations | 1 site (Linköping) |
| Trial ID | NCT06753435 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include Swedish- or English-speaking parents over 18 with infants born between gestational weeks 30+0 and 34+6.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Linköping
- H.R.H Crown Princess Victoria's Children's and Youth Hospital — Linköping, Sweden (RECRUITING)
Study contacts
- Study coordinator: Evalotte Mörelius, PhD, Professor
- Email: evalotte.morelius@liu.se
- Phone: +46 (0) 793008207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm, Preterm infant, Stress system, Family