Co-regulation and Interaction in the NICU
Launched by LINKOEPING UNIVERSITY · Dec 20, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Co-regulation and Interaction in the NICU," is studying how preterm infants and their parents interact during stressful moments in the neonatal intensive care unit (NICU). Preterm infants often experience stress that can affect their brain development, potentially leading to problems later in life. The researchers want to see if better parent-infant interactions can help reduce this stress and its negative effects. They will collect saliva samples from both the parents and infants to measure stress hormones, while also recording their interactions during specific care routines. This study aims to understand how these interactions can be improved to better support preterm infants.
To participate in this trial, families must have a baby born between 30 to 34 weeks of gestation and parents who speak Swedish or English and are over 18 years old. Those with certain medical conditions or medications that affect hormone levels, as well as infants with significant health issues, will not be eligible. Participants can expect to be involved in three video-recorded procedures in the NICU, where their interactions will be observed and analyzed. This research is important because it may lead to better care strategies that can reduce stress for preterm infants and enhance their development.
Gender
ALL
Eligibility 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.
About Linkoeping University
Linköping University is a leading academic institution in Sweden, renowned for its innovative research and commitment to advancing medical science. With a strong emphasis on interdisciplinary collaboration, the university facilitates cutting-edge clinical trials aimed at improving patient outcomes and enhancing healthcare delivery. Linköping University’s research initiatives are supported by state-of-the-art facilities and a robust network of partnerships with healthcare providers, industry stakeholders, and regulatory bodies, ensuring rigorous methodologies and ethical standards in all clinical investigations. Through its dedication to research excellence, Linköping University plays a pivotal role in translating scientific discoveries into practical applications that benefit society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Linköping, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported