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Completed

NCT Number: NCT05805254

Neurofunctional Study of Preterm Infants' Brain Activity

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.

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Key information

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Burlo Garofolo

Trieste, 34137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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