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Search / Trial NCT05853991

Effects of Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants

Launched by COME COLLABORATION · May 2, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how touch can help improve the health and development of preterm infants, those born between 32 and 34 weeks of pregnancy. The researchers believe that gentle touch and close physical contact with caregivers can positively affect the brain and body of these babies, helping them grow better and develop important skills like social interaction. They will use advanced imaging techniques to study changes in brain activity and metabolism in response to touch.

To be eligible for this trial, infants must be born within the specified gestational age and not have any serious health issues that could complicate their care. Parents or guardians will need to give their consent for their baby to participate. While the trial is not yet recruiting participants, it aims to provide valuable insights into how specific touch therapies can support the health of preterm infants, ultimately helping them thrive as they grow.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Preterm birth, between 32.0 and 33.6 weeks gestational age (GA);
  • Absence of comorbidities that could affect the stability of vital parameters, and therefore represent a contraindication to the proposed intervention. Comorbities include sepsis, pathologies pertaining to surgery, respiratory or cardiovascular instability, birth from a drug-addicted or HIV-positive mother) or known congenital pathologies;
  • Obtaining informed consent for participation in this research project from parents or legal guardians.
  • Exclusion Criteria:
  • Preterm infants born before 32.0 weeks of GA and after 34 weeks and with respiratory and neurological pathologies and any additional comorbities.
  • Children whose parents will not read and sign or in case of failure to obtain informed consent will be excluded from the study.

About Come Collaboration

Come Collaboration is a pioneering clinical trial sponsor dedicated to advancing medical research through innovative partnerships and collaborative efforts. With a focus on enhancing patient outcomes, we leverage cutting-edge methodologies and a robust network of healthcare professionals to design and execute trials that are both efficient and ethically sound. Our commitment to transparency and scientific integrity ensures that our studies adhere to the highest regulatory standards, ultimately driving the development of transformative therapies. By fostering a culture of collaboration, Come Collaboration aims to bridge the gap between research and real-world application, making significant strides in the landscape of clinical development.

Locations

Milan, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported