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

NCT04293939 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-10-18

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Functional Magnetic Risonance Imaging (fMRI) acquisition

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.

Sponsors & Collaborators

  • IRCCS Eugenio Medea

    lead OTHER

Eligibility

Min Age
6 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2024-04-04
Completion
2024-09-04

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293939 on ClinicalTrials.gov