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NCT05805254
Neurofunctional Study of Preterm Infants' Brain Activity
trial in Brain Activity in 30 participants. Completed in 8 August 2022.
8 August 2022
Quick facts
| Lead sponsor | IRCCS Burlo Garofolo |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 25 March 2018 |
| Primary completion | 8 August 2022 |
| Estimated completion | 8 August 2022 |
| Sites | 1 location across Italy |
Conditions studied
- Brain Activity — all drugs for Brain Activity →
- Preterm — all drugs for Preterm →
Sponsor
IRCCS Burlo Garofolo — full company profile →
Who can join
Under 28 Days, any sex, with Brain Activity or Preterm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05805254
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other IRCCS Burlo Garofolo trials
Trials by the same sponsor.
- NCT06895278 — Articular Damage in Patients With Juvenile Idiopathic Arthritis After Transition to Adult Care · not yet recruiting
- NCT05821569 — Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding · unknown
- NCT06310421 — Spinal Muscular Atrophy Neonatal Screening Program · recruiting
- NCT05806372 — Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy · unknown
- NCT06324578 — Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05805254 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Burlo Garofolo
- Last refreshed: 12 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05805254.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing