Neurofunctional Study of Preterm Infants' Brain Activity

Preterm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805254
• Other study ID #: RC 02/17
• Status: Completed
• Start date: March 25, 2018
• Est. completion date: August 8, 2022

Study information

• Verified date: April 2023
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Brain Activity
• Premature Birth
• Preterm

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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