Skin-to-skin Contact in Neonatal Intensive Care Unit (NICU), Caregiving Touch and Neural Correlates of Slow Stroking Touch in Preterm Infants

NCT04293939 | Unknown

• 1 other identifier: SG-2018-12368279
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm (PT) infants spend their first weeks of life in Neonatal Intensive Care Unit (NICU) where receive little affective physical contact, which plays a crucial role in brain development. Evidence indicates that skin-to-skin contact (SSC) has a positive effect on infants' neurophysiological and behavioral adjustment to postnatal life. Moreover, caregiving touch during early interactions is related to sensitive caregiving behavior, which in turn is associated with brain connectivity in full-term (FT) infants. Despite the importance of both SSC and caregiving touch for infant development little is known about the neural correlates of early physical contact in PT infants. Using MRI the project aims to investigate the association between brain responses to gentle skin stroking at 2 months examining the effects of: (1) the birth status (PT vs. FT); (2) the duration of SSC in NICU; (3) the caregiving touch in the home environment and during mother-infant interaction. The investigators hypothesized: (1) differences in the brain responses in the above mentioned ROIs to gentle skin stroking, a type of tactile stimulus associated with affectionate touch and social interaction26, between FT infants and PT infants: (2) that above mentioned putative differences would be mitigate by duration of SSC during the NICU in PT infants; (3) an association between CT/sensitive caregiving behaviors both in the home environment and during face-to-face interaction and brain response in the above mentioned ROIs to gentle skin stroking in PT and FT infants.

Conditions

Preterm Birth; Parent-Child Relations

Keywords

At-risk Infants; Skin-to-skin contact; Insular cortex

Outcome Measures

Primary Outcomes (1)

• Insular cortex and somatosensory cortex activation in preterm and full-term infants

  Significant differences in mean BOLD signal magnitude in the insular cortex and in somatosensory cortex between preterm infants and full-term infants in the slow skin stroking experimental task during the fMRI session

  experimental MRI scanning visit occurring when the infants is 2 months-old (Corrected Age for preterm infants)

Secondary Outcomes (4)

• Skin-to-skin contact in NICU and insular cortex/somatosensory cortex activation in preterm infants

  during NICU stay (from birth to NICU discharge) and when the infants is 2 months-old (Corrected Age for preterm infants)

• Caregiver touch (duration) and insular cortex/somatosensory cortex activation in preterm and full term infants

  for preterm infants: from NICU discharge to 2 months (Corrected Age); for full-term infants: from birth to 2 months

• Caregiver touch (quality) and insular cortex/somatosensory cortex activation in preterm and full term infants

  for preterm infants: from NICU discharge to 2 months (Corrected Age); for full-term infants: from birth to 2 months

• Sensitive caregiving behaviors and insular cortex/somatosensory cortex activation in preterm and full term infants

  for preterm infants: from NICU discharge to 2 months (Corrected Age); for full-term infants: from birth to 2 months

Study Arms (2)

Preterm children

Children born before the 37th week of gestation: clinical sample

Diagnostic Test: Functional Magnetic Risonance Imaging (fMRI) acquisition

Full-term children

Children born after the 37th week of gestation: control sample

Diagnostic Test: Functional Magnetic Risonance Imaging (fMRI) acquisition

Interventions

Functional Magnetic Risonance Imaging (fMRI) acquisition DIAGNOSTIC_TEST

Infants will undergo an MRI exam with a 3 Tesla Philips Achieva scanner and a 32-channel head coil. MRI Protocol: T1 weighted image structural, T2 weighted image structural, fMRI task. Task fMRI: experiment will be implemented using the block design is as follow: 1.Rest (control condition): no touch; 2.Soft touch (stimulus condition): gentle strokes on infant's right leg (\~15 cm area) with a soft brush at a velocity of \~5 cm/s Stimulus blocks will last for \~15s, allowing the blood-oxygen-level-dependen (BOLD) signal to reach the steady state. Control blocks duration will be randomized (10-18s) to avoid foresee activation phenomena. Condition will be administered multiple times (\~10 times). Two run will be administered. The stimulus will be administered using a soft brush. A regular audio signal will help the operator to keep a constant stroke velocity. Audio commands will also be used to direct the operator. Infant must be asleep (natural sleep) during the fMRI acquisition.

Full-term children; Preterm children

Eligibility Criteria

• Age: 6 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Full-term infants. Mothers and their infants will be enrolled during the prenatal/postnatal parenting course at: (a) S. Gerardo Hospital, Monza; (b) Merate Hospital, Lecco; (c) Carate Hospital, Lecco; (d) other privat perinatal services in Lecco area. Following a letter outlining the general research, parents will be contacted by telephone and asked to voluntarily participate. Preterm infants. Preterm infants infants will be pre-screened for medical status variables by the NICU neonatologists of: (a) S. Gerardo Hospital, Monza; (b) A. Manzoni Hospital, Lecco; (c) Valduce Hospital, Como. Following a letter outlining the general research, parents will be meet per person in NICU or contacted by telephone and asked to voluntarily participate.

You may qualify if:

• Gestational age (GA) \< or = 37 weeks
• age-appropriate neurological examination

You may not qualify if:

• presence of perinatal injuries/genetic syndromes
• documented neurological pathology
• presence of sensory deficits
• Full-term infants (control sample)
• Gestational age (GA) \> 37 weeks
• age-appropriate neurological examination
• presence of perinatal injuries/complications
• presence of sensory deficits
• Age over 18 years
• Good comprehension of Italian language
• No documented cognitive/psychiatric impairments
• No documented psychotropic medication during pregnancy
• No single-parent families

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Associalzione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Eleonora Mascheroni

CONTACT

+39031877464; eleonora.mascheroni@lanostrafamiglia.it

Rosario Montirosso

CONTACT

+39031877494; rosario.montirosso@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 3, 2020
• Study Start: December 2, 2019
• Primary Completion: April 4, 2024
• Study Completion: September 4, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

IT (1)