Co-regulation and Interaction in the NICU
ConditionPreterm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorLinkoeping University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Swedish- or English-speaking parents aged over 18, born in Europe, and their infants born between gestational weeks 30+0 and 34+6.
Disqualifiers
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 population
Infants born preterm between 30+0 and 34+6 weeks gestational age and their parents \> 18 years old
Trial design
Design model
Family-based
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
105 Participants
are grouped into 1 trial groupGroup A: Families of preterm babies born at GA 30+0-34+6 enrolled in NICU
Trial outcomes
Primary outcomes
1
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).
Time frame
GW 32 +/- 2 weeks2
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).
Time frame
GW 32 +/- 2 weeks3
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.
Time frame
GW 32 +/- 2 weeks4
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.
Time frame
GW 32 +/- 2 weeksSecondary outcomes
1
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.
Time frame
GW 32 +/- 2 weeks2
Infant development
The Swedish Ages and Stages Questionnaire: Social Emotional (ASQSE2) is a 25-item tool assessing children's social-emotional development.
Time frame
6 and 12 months corrected age, +/-2 months3
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.
Time frame
6 and 12 months corrected age, +/-2 months4
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.
Time frame
12 months corrected age, +/-2 monthsOther outcomes
1
Parental-to-infant emotional bonding
The Swedish version of the Mother-to-Infant-Bonding-Scale (MIBS), which assesses parental emotions toward their infants over the past ten days using a 4-point Likert scale ranging 0-3. Higher scores indicate more bonding challenges.
Time frame
GW 32 +/- 2 weeks2
Parental postpartum depression
The well-established Edinburgh Postnatal Depression Scale (EPDS, a ten-item questionnaire scoring symptoms of depression in new parents over the past week on a scale ranging from 0 to 3, higher scores indicating more symptoms of depression.
Time frame
GW 32 +/- 2 weeks3
Parental well-being
World Health Organization-5 (WHO-5), comprising six questions measuring well-being on a scale of 0-5 points scale, with scores translated to a percentage where 100% indicates maximum well-being.
Time frame
GW 32 +/- 2 weeks4
Parental anxiety
Spielberger's Anxiety Inventory-State short version has six questions measuring anxiety (right now) on a 4-point likert scale. Total scores range from 6-24, higher scores indicate more anxiety.
Time frame
GW 32 +/- 2 weeksSponsors and contacts
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Linkoeping University
Lead sponsor
Region Östergötland
Collaborator
Source ClinicalTrials.gov