PretermCORINCT06753435
Co-regulation and Interaction in the NICU
An observational study of Preterm, run by Linkoeping University at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 days and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm
- How many people
- 105 participants
- Where
- 1 siteSweden
- Study dates
- 7 Jan 2025to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Infants born preterm between 30+0 and 34+6 weeks gestational age and their parents > 18 years old
Who may be able to join
- Swedish- or English-speaking parents aged over 18, born in Europe, and their infants born between gestational weeks 30+0 and 34+6.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
H.R.H Crown Princess Victoria's Children's and Youth Hospital
Linköping, 58185
Neonatal Intensive Care Unit, +46 (0)10 103 00 00, BarnUsBkc@regionostergotland.se
Evalotte Mörelius, RN, PhD, Professor
About this study
Official title: Development of the Premature Infant's Stress System. Focus on Parent-infant Co-regulation and Interaction
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.
Read more
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.
Read the detailed description
This observational study adopts a correlational approach to investigate biological co-regulation and parent-infant interaction within families of preterm infants, utilizing a within-family design. Data collection occurs at multiple time points in the NICU, and at 6 and 12 months corrected age. To study parent-infant synchrony and co-regulation with both parents, both should be present and perform three diaper changes in three days. Two will be perforemd by the mother and one by the father. All occassions will be video recorded to study interaction and saliva will be collected before and after the procedure to study co-regulation in cortisol and alpha-amylase during baseline, reactivity and recocvery. At 6 and 12 months parents will respond to questionnaires regarding the child's behavior and development.
Sample size: A power calculation shows sample size of n=28 is sufficient, considering α (two-tailed) = 0.05, β = 0.20, and ICC = 0.5.To consider attrition, we paln to include 35 families.
- Conditions
- Preterm
- Keywords
- Preterm infant, Stress system, Family
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Families of preterm babies born at GA 30+0-34+6 enrolled in NICU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva cortisol correlation (co-regulation) within the triad (mother, father, infant)
Saliva will be collected from the infant and both parents before (baseline) and at 20 minutes (reactivity), and 40 minutes (recovery) after a diaper change performed three times in three days. Samples will be collected using swabs and stored frozen (-80C) until analysis. Cortisol will be analysed at Linköping University (LiU).
Measured: GW 32 +/- 2 weeks
Saliva Alpha-amylase correlation (co-regulation) within the triad (mother, father, infant)
Saliva α-amylase will be collected from the infant and both parents before (baseline) and at 5 minutes (reactivity), 20 minutes (recovery) after a diaper change performed three times in three days. Samples will be collected using swabs and stored frozen (-80C) until analysis. α-amylase levels will be analysed at Linköping University (LiU).
Measured: GW 32 +/- 2 weeks
Parent-infant emotional availability
All three diaper changes will be video recorded with both parents present and instructed to act as they normally would. Emotional availability will be evaluated from videos using the Emotional Availability Scales (EAS) by certified coders. EAS assesses dyadic and emotional qualities of parent-infant relationships across six sub-scales, with dimensions measured using a Likert-scale ranging from 1 to 7, higher scores indicate better emotional availability.
Measured: GW 32 +/- 2 weeks
Parent-infant synchrony
All three diaper changes will be video recorded with both parents present and instructed to act as they normally would. Parent-infant synchrony will be assessed from the videos using the Dyadic Mini Code, which includes six categories: mutual attention, positive affect, turn-taking, parental pauses, infant cues, and parental sensitive responsiveness. Scores range from 6 to 12, with ≥10 indicating synchronous interaction.
Measured: GW 32 +/- 2 weeks
Parent-infant interaction
All three diaper changes will be video recorded with both parents present and instructed to act as they normally would. Parent sensitivity towards the infant will be assessed from the videos using Ainsworth's Sensitivity Scales. This instrument constitutes of four sub-scales measuring sensitivity, cooperation, availability and acceptance. Each scale range 1-9, where higher scores indicate better interactive behaviour.
Measured: GW 32 +/- 2 weeks
Secondary outcomes (4)
Skin temperature in mother, father and infant
Correlation of skin temperature in the triad will be measured at the forehead on infants and both parents before and after each diaper change with an infrared thermometer. This method is painless as the temperature can be assessed without touching the infant.
Measured: GW 32 +/- 2 weeks
Infant development
The Swedish Ages and Stages Questionnaire: Social Emotional (ASQSE2) is a 25-item tool assessing children's social-emotional development.
Measured: 6 and 12 months corrected age, +/-2 months
Infant temperament
Infant Behaviour Questionnaire-Revised short form, which assesses infants' temperament across three main components (negative emotionality, positive affectivity/surgency, and orienting/regulatory capacity), will be administered when infants are 6 and 12 months corrected age. This questionnaire includes 14 scales measured on 7-point-scales. A min-max score for each scale is 1-7 where 7 indicates a higher frequency of the specific behaviours being measured.
Measured: 6 and 12 months corrected age, +/-2 months
Communicative Skills and Language Abilities
The Early Communicative Development Inventories (words \& gestures), assess communicative skills and language abilities of infants aged 8-16 months. The Swedish version will be used to evaluate the child's understanding of words, vocabulary, and communicative gestures. Confirmative answers are given in a form of examples.
Measured: 12 months corrected age, +/-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start7 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Region Östergötland
- Responsible party
- Principal investigator, Evalotte Morelius, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753435
- Sponsor's protocol ID
- Dnr 2024-02916-01 CORI
- Acronym
- CORI
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Premature Infant's Stress System. Focus on Parent-infant Co-regulation and Interaction
- ClinicalTrials.gov ID
- NCT06753435
- Acronym / sponsor ID
- CORI / Dnr 2024-02916-01 CORI
- Conditions
- Preterm
- Keywords
- Preterm infant, Stress system, Family
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Region Östergötland
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This observational study adopts a correlational approach to investigate biological co-regulation and parent-infant interaction within families of preterm infants, utilizing a within-family design. Data collection occurs at multiple time points in the NICU, and at 6 and 12 months corrected age. To study parent-infant synchrony and co-regulation with both parents, both should be present and perform three diaper changes in three days. Two will be perforemd by the mother and one by the father. All occassions will be video recorded to study interaction and saliva will be collected before and after the procedure to study co-regulation in cortisol and alpha-amylase during baseline, reactivity and recocvery. At 6 and 12 months parents will respond to questionnaires regarding the child's behavior and development.
Sample size: A power calculation shows sample size of n=28 is sufficient, considering α (two-tailed) = 0.05, β = 0.20, and ICC = 0.5.To consider attrition, we paln to include 35 families.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families of preterm babies born at GA 30+0-34+6 enrolled in NICU | – | – |
Who may qualify
- Ages
- 2 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born preterm between 30+0 and 34+6 weeks gestational age and their parents > 18 years old
Key inclusion criteria (1 listed)
- Swedish- or English-speaking parents aged over 18, born in Europe, and their infants born between gestational weeks 30+0 and 34+6.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Saliva cortisol correlation (co-regulation) within the triad (mother, father, infant)
Time frame: GW 32 +/- 2 weeks
Saliva will be collected from the infant and both parents before (baseline) and at 20 minutes (reactivity), and 40 minutes (recovery) after a diaper change performed three times in three days. Samples will be collected using swabs and stored frozen (-80C) until analysis. Cortisol will be analysed at Linköping University (LiU).
Saliva Alpha-amylase correlation (co-regulation) within the triad (mother, father, infant)
Time frame: GW 32 +/- 2 weeks
Saliva α-amylase will be collected from the infant and both parents before (baseline) and at 5 minutes (reactivity), 20 minutes (recovery) after a diaper change performed three times in three days. Samples will be collected using swabs and stored frozen (-80C) until analysis. α-amylase levels will be analysed at Linköping University (LiU).
Parent-infant emotional availability
Time frame: GW 32 +/- 2 weeks
All three diaper changes will be video recorded with both parents present and instructed to act as they normally would. Emotional availability will be evaluated from videos using the Emotional Availability Scales (EAS) by certified coders. EAS assesses dyadic and emotional qualities of parent-infant relationships across six sub-scales, with dimensions measured using a Likert-scale ranging from 1 to 7, higher scores indicate better emotional availability.
Parent-infant synchrony
Time frame: GW 32 +/- 2 weeks
All three diaper changes will be video recorded with both parents present and instructed to act as they normally would. Parent-infant synchrony will be assessed from the videos using the Dyadic Mini Code, which includes six categories: mutual attention, positive affect, turn-taking, parental pauses, infant cues, and parental sensitive responsiveness. Scores range from 6 to 12, with ≥10 indicating synchronous interaction.
Parent-infant interaction
Time frame: GW 32 +/- 2 weeks
All three diaper changes will be video recorded with both parents present and instructed to act as they normally would. Parent sensitivity towards the infant will be assessed from the videos using Ainsworth's Sensitivity Scales. This instrument constitutes of four sub-scales measuring sensitivity, cooperation, availability and acceptance. Each scale range 1-9, where higher scores indicate better interactive behaviour.
4 secondary outcomes
Skin temperature in mother, father and infant
Time frame: GW 32 +/- 2 weeks
Infant development
Time frame: 6 and 12 months corrected age, +/-2 months
Infant temperament
Time frame: 6 and 12 months corrected age, +/-2 months
Communicative Skills and Language Abilities
Time frame: 12 months corrected age, +/-2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evalotte Mörelius, PhD, Professor (+46 (0) 793008207, evalotte.morelius@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva cortisol correlation (co-regulation) within the triad (mother, father, infant) (time frame: GW 32 +/- 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.