Actively Recruiting
Development of the Premature Infant's Stress System Focusing on Parent-Infant Co-regulation and Interaction in the NICU
Led by Linkoeping University · Updated on 2025-03-07
105
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
L
Linkoeping University
Lead Sponsor
R
Region Östergötland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying families of preterm infants born between gestational weeks 30+0 and 34+6 to understand how stress affects infants' developing brains and the role of parent-infant interaction in managing stress. The study focuses on biological co-regulation of stress markers like cortisol and alpha-amylase, and social-emotional interactions between the infant and both parents during a critical sensitive period. This observational study aims to fill gaps in knowledge about stress markers and parent-infant synchrony in the neonatal intensive care unit (NICU). The study involves 35 families participating in three diaper change procedures in the NICU, with both parents present. Two diaper changes will be done by the mother and one by the father, all video-recorded to analyze parent-infant interaction. Saliva samples will be collected from infants and both parents before and after each procedure to measure co-regulation of cortisol and alpha-amylase. Follow-up assessments include questionnaires about the child's behavior and development at 6 and 12 months corrected age. Participants will be involved in multiple video-recorded procedures in the NICU and provide saliva samples to study stress hormone patterns and parent-infant interaction. Researchers will analyze videos using validated scales to assess emotional availability and synchrony between parents and infant. Additional measures include infant temperament, development, communicative skills, and language abilities at follow-ups. The study will provide important insights needed to design nursing interventions to reduce stress effects in preterm infants.
CONDITIONS
Brief Title
Co-regulation and Interaction in the NICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents must be over 18 years old, speak Swedish or English, and be born in Europe
- Infants born between gestational weeks 30+0 and 34+6
- Both parents must be present to perform diaper changes in the NICU
- Parents must be able to complete follow-up questionnaires at 6 and 12 months corrected age
You will not qualify if you...
- Parents with conditions or taking medications that affect the hormone system
- Infants with major malformations or complex care needs that prevent parent-infant interaction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 weeks during NICU stay
Participants' biological co-regulation and parent-infant interaction are observed within the NICU through video recordings and saliva sample collections during diaper changes.
3 visits for diaper changes in the NICU (2 by mother, 1 by father)
Duration - From 6 to 12 months corrected age
Parents complete questionnaires about their child's behavior, development, temperament, and communicative skills at 6 and 12 months corrected age.
2 questionnaire visits at 6 and 12 months corrected age
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
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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