Clinical trial NCT05805254: Neurofunctional Study of Preterm Infants' Brain Activity
Official title: Neurofunctional Study of the Brain Activity of Preterm Infants During Family-centered Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Activity
Preterm
Keywords: Preterm infant
Kangaroo Mother care
family-centered interventions
near-infrared spectroscopy
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 30
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants with gestational age at birth ≤32 weeks

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.


Eligibility criteria: 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

Primary outcomes:
measure: Values of cortical oxy-haemoglobin (HbO2) during KMC in preterm infants
timeFrame: During hospital stay, between 30 to 36 weeks of postmenstrual age
Secondary outcomes:
measure: 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
timeFrame: During hospital stay, between 30 to 36 weeks of postmenstrual age
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS materno infantile Burlo Garofolo
name: Stefano Bembich, MSC
role: STUDY_DIRECTOR
References: