Co-regulation and Interaction in the NICU

NCT06753435 | Recruiting

• 1 other identifier: Dnr 2024-02916-01 CORI
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Preterm

Keywords

Preterm infant; Stress system; Family

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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.

  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.

  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.

  GW 32 +/- 2 weeks

Secondary Outcomes (4)

• Skin temperature in mother, father and infant

  GW 32 +/- 2 weeks

• Infant development

  6 and 12 months corrected age, +/-2 months

• Infant temperament

  6 and 12 months corrected age, +/-2 months

• Communicative Skills and Language Abilities

  12 months corrected age, +/-2 months

Other Outcomes (6)

• Parental-to-infant emotional bonding

  GW 32 +/- 2 weeks

• Parental postpartum depression

  GW 32 +/- 2 weeks

• Parental well-being

  GW 32 +/- 2 weeks

Study Arms (1)

Families of preterm babies born at GA 30+0-34+6 enrolled in NICU

Eligibility Criteria

• Age: 2 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infants born preterm between 30+0 and 34+6 weeks gestational age and their parents \> 18 years old

You may qualify if:

• Swedish- or English-speaking parents aged over 18, born in Europe, and their infants born between gestational weeks 30+0 and 34+6.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linkoeping University: lead
• Region Östergötland: collaborator

Study Sites (1)

H.R.H Crown Princess Victoria's Children's and Youth Hospital

Linköping, 58185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva for analyse of cortisol and alpha-amylase

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Evalotte Mörelius, PhD, Professor

CONTACT

+46 (0) 793008207; evalotte.morelius@liu.se

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 31, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

SE (1)