Neurofunctional Study of Preterm Infants' Brain Activity

NCT05805254 | Completed

• 1 other identifier: RC 02/17
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

During hospital stay, a family centered therapeutic approach is increasingly seen as the preferred clinical and care model to be adopted, since it is effective in promoting the neurobehavioral development of the infant and the psychophysical health of the family. In preterm infant, parental relationship and parental relationship-centered interventions, such as kangaroo mother care (KMC), are actively promoted. Studies carried out with electroencephalography showed that preterm infants who participated in KMC interventions have, when reach term equivalent age, a similar level of maturity as healthy full-term infants. It has also been observed that KMC carried out in preterm infant with gestational age \<33 weeks promotes adequate development of the primary motor cortex during adolescence. Recent scientific evidence showed an early response to relational stimulations, in particular to their emotional content, of term infants. After few days of life, the infant's brain picks up messages from the human context and interacts with them. For example, a study using near-infrared spectroscopy (NIRS) showed increased activation of the right frontal cortex in infants in association with their mother's direct speech. Similar neuroimaging studies have not yet been conducted in preterm infants during hospitalization. The aim of this study is to assess the activation of the cerebral cortex of the preterm infant in the course of 1) KMC and 2) listening to their mother's voice, using optical topography, a multichannel NIRS system.

Conditions

Brain Activity; Preterm

Keywords

Preterm infant; Kangaroo Mother care; family-centered interventions; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• Values of cortical oxy-haemoglobin (HbO2) during KMC in preterm infants

  Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring cortical oxy-haemoglobin (HbO2) values

  During hospital stay, between 30 to 36 weeks of postmenstrual age

Secondary Outcomes (1)

• Values of cortical oxy-haemoglobin (HbO2) during the experience of listening the mother's voice and the voice of an unknown woman in preterm infants

  During hospital stay, between 30 to 36 weeks of postmenstrual age

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants with gestational age at birth ≤32 weeks

You may qualify if:

• gestational age at birth ≤32 weeks
• absence of brain injury and neurological problems
• newborn-mother pairs in KMC
• adherence to research by parents.

You may not qualify if:

• contraindications to KMC and NIRS, according to internal protocol

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Stefano Bembich, MSC

  IRCCS materno infantile Burlo Garofolo

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 7, 2023
• Study Start: March 25, 2018
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

IT (1)