Efficacy of an Early Rhythmic Intervention in Infancy

Status Enrolling by invitation

Clinical Trial Summary

The present project develops from a wide research line aiming at identifying very early electrophysiological risk markers for neurodevelopmental disorders. Long-term goals of the study include the characterization of language/learning developmental trajectories in children at high risk for language disorders and the implementation of ecological interventions based on enriched auditory experience to be employed to these children in an attempt to modify their atypical developmental trajectory before the emergence and crystallization of any behavioural symptoms and within the early period of known maximum cerebral plasticity. Specifically, the main aim of this study is the development and implementation of an innovative and ecological early intervention based on environmental auditory enrichment (labelled "rhythmic intervention"). This intervention is tested both on a sample of typically developing infants and on a sample of infants at high familial risk for language disorders during a time span between 7 and 9 months of age. The efficacy of the intervention is tested on the electrophysiological markers tested before and after the intervention activities and on the linguistic outcomes within a longitudinal approach. The efficacy of such an intervention is compared to the spontaneous development observed in comparable groups of infants with and without familial risk for language disorders. In addition, only in a group of typically developing infants, a control intervention providing passive exposure to the same auditory stimulation is tested, in order to verify the specific contribution of the active participation of the children to the intervention. The investigators hypothesize that the rhythmic intervention may modify the electrophysiological markers underlying auditory processing and the linguistic skills of all children, with a larger increase in infants at familial risk for language disorders who are specifically impaired in such skills.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04755309
Study type	Interventional
Source	IRCCS Eugenio Medea
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	February 1, 2021
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05793112` - INF108F in Infants With Food Protein Induced Proctocolitis	Phase 4
Recruiting	`NCT03828708` - Early Iron Exposure on the Gut Microbiota in Young Infants	N/A
Recruiting	`NCT06018064` - Investigating Fit and Satisfaction of the Prone Positioner	N/A
Not yet recruiting	`NCT06335524` - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants	N/A
Not yet recruiting	`NCT05039918` - Neonatal Experience of Social Touch	N/A
Completed	`NCT01166867` - A Pilot Study Using Photo-plethysmographic (PPG) Camera
Completed	`NCT00791466` - Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development	N/A
Completed	`NCT03331276` - Growth and Safety Study of an Infant Formula for Healthy Term Infants	N/A
Completed	`NCT05157633` - Oral Exploration of Objects and Food Diversification
Completed	`NCT05217186` - Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Recruiting	`NCT05006989` - Blueberry Intake and Infant Gut Health	N/A
Completed	`NCT04901611` - Parental Touch Trial (Petal)	N/A
Completed	`NCT03082313` - Movement-based Infant Intervention	N/A
Recruiting	`NCT06053515` - Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication	N/A
Completed	`NCT05394883` - The SPROUT (Pilot) Project	N/A
Completed	`NCT03991949` - Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula	N/A
Active, not recruiting	`NCT03851120` - Brain Probiotic and LC-PUFA Intervention for Optimum Early Life	Phase 2
Completed	`NCT03662048` - Improving Infant Sleep Safety With the Electronic Health Record	N/A
Active, not recruiting	`NCT04749888` - Impact of the Korea Early Childhood Home-visiting Intervention	N/A
Recruiting	`NCT06230848` - Multisensory Early Oral Administration of Human Milk in Preterm Infants	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.