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Clinical Trials in France / NCT05404594
Active, not recruiting Not applicable

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

NCT05404594 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Not applicable
Started
2019-07-17
Last updated
2026-08-25

Condition(s) studied

Procedural PainPre-TermVenipuncture

Investigational drug(s) / intervention(s)

Maternal vocal contact

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.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • The cortical hemodynamic response profile(changes in oxyhemoglobin levels in the somato-sensory areas) in response to venipuncture performed with a recommended standard nonpharmacological analgesic treatment (non-nutritive sucking, and sweet solution) — During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI and at 2 to 3 days of life in term neonates.
    The measurements will be performed using receiver and transmitter optodes to measure the variations of oxy and deoxyhemoglobin in the cerebral cortex below the optodes. The optodes will be placed in the primary and secondary somatosensory areas, and in other cortical areas (nociceptive pathway and control areas) using the EEG 10-20 classification. The data set will be collected over a basal period, a stimulation period and a post-stimulation period. Response patterns will be analyzed by mixed models and compared in VPIs in the different APM groups and with term neonates. A typical response associates an increase in oxyhemoglobin (Hb02) with a concomitant stability or decrease in deoxyhemoglobin (HHb).

Trial sites (1)

FacilityCityRegionStatus
Service de Pédiatrie - Hôpital d'Hautepierre Strasbourg France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05404594 on ClinicalTrials.gov ↗ ← All trials in France