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Neurofunctional Study of Preterm Infants' Brain Activity

Neurofunctional Study of the Brain Activity of Preterm Infants During Family-centered Interventions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05805254
Enrollment
30
Registered
2023-04-07
Start date
2018-03-25
Completion date
2022-08-08
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Activity, Preterm

Keywords

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

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.

Interventions

None listed

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* contraindications to KMC and NIRS, according to internal protocol

Design outcomes

Primary

MeasureTime frameDescription
Values of cortical oxy-haemoglobin (HbO2) during KMC in preterm infantsDuring hospital stay, between 30 to 36 weeks of postmenstrual ageMultichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring cortical oxy-haemoglobin (HbO2) values

Secondary

MeasureTime frameDescription
Values of cortical oxy-haemoglobin (HbO2) during the experience of listening the mother's voice and the voice of an unknown woman in preterm infantsDuring hospital stay, between 30 to 36 weeks of postmenstrual ageMultichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring cortical oxy-haemoglobin (HbO2) values

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026