NCT05404594

Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The management of pain related to venipuncture remains insufficient in very preterm infants (VPI. The separation between the mother (father) and her(his) child can aggravate the short-term painful experience of the newborn. Accurate diagnosis and treatment of pain is necessary to preserve the well-being and brain development of VPI. A better understanding of the development of pain pathways and the cortical integration of nociceptive messages is essential to reach this goal.

Conditions

• Procedural Pain
• Pre-Term
• Venipuncture

Interventions

Type	Name	Description
BEHAVIORAL	Maternal vocal contact	Two consecutive venipuncture (order randomly balanced) within a short period of time will be realized with and without the presence of the mother talking/singing to her VPI infant. In this intervention group, the mother will be supported to talk or to sing to her infants during before and during the venipuncture.

Timeline

• Start date: 2019-07-17
• Primary completion: 2023-04-17
• Completion: 2023-04-17
• First posted: 2022-06-03
• Last updated: 2023-01-30

Locations

1 site across 1 country: France