Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants (NOCI-Prem)

University Hospital, Strasbourg, France

Status

Enrolling

Conditions

Pre-Term

Procedural Pain

Venipuncture

Treatments

Behavioral: Maternal vocal contact

Study type

Interventional

Funder types

Other

Identifiers

NCT05404594

7256

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Experimental group: VPIs of gestational age less than or equal to 33 weeks on the day of birth and hospitalized in the neonatal intermediate care unit or the neonatal intensive care unit of the Neonatal department of the Hautepierre Hospital (Strasbourg University Hospital)
- Control group: Healthy full-term babies (> 37 weeks gestational age) hospitalized in the maternity ward of Strasbourg University Hospital
- Consent obtained from both parents
- Subject affiliated to a social health insurance plan.

Exclusion criteria

- Any malformation known before inclusion
Cerebral lesions discovered on cerebral ultrasound performed as part of the standard management of newborns (Intra-Ventricular Hemorrhages of grade III or IV of the Papile classification, Periventricular Leucomalacia)
Unstable clinical status according to the investigator's judgment
Expected transfer of the child to another hospital before the term of 40 weeks PMAs.