Clinical trial NCT05404594: Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
Official title: Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Pain
Pre-Term
Venipuncture
Keywords: Very preterm infants
Development of nociception
Cortical hemodynamic responses
Pain indicators
Gender
Maternal voice
Oxytocin
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 criteria: 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 outcomes:
measure: The cortical hemodynamic response profile
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: The cortical hemodynamic response profile
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: The cortical hemodynamic response profile
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: The cortical hemodynamic response profile
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
Secondary outcomes:
measure: Comparison of the hemodynamic response profiles and salivary oxytocin levels
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: Comparison of the hemodynamic response profiles and salivary oxytocin levels
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: Comparison of the hemodynamic response profiles and salivary oxytocin levels
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: Comparison of the hemodynamic response profiles and salivary oxytocin levels
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
measure: Analysis of the impact on the responses of maternal separation
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: Analysis of the impact on the responses of maternal separation
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: Analysis of the impact on the responses of maternal separation
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: Analysis of the impact on the responses of maternal separation
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
measure: Comparison of the response profiles according to the sex
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: Comparison of the response profiles according to the sex
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: Comparison of the response profiles according to the sex
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: Comparison of the response profiles according to the sex
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
measure: Comparison of conduction velocities of small caliber nociceptive fibers
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: Comparison of conduction velocities of small caliber nociceptive fibers
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: Comparison of conduction velocities of small caliber nociceptive fibers
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: Comparison of conduction velocities of small caliber nociceptive fibers
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
measure: Correlational analyses by APM group
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: Correlational analyses by APM group
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: Correlational analyses by APM group
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: Correlational analyses by APM group
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
measure: Facial pain behavior
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: Facial pain behavior
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: Facial pain behavior
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: Facial pain behavior
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
measure: Pain index
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: Pain index
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: Pain index
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: Pain index
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
measure: Cortical evoked potentials
timeFrame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
measure: Cortical evoked potentials
timeFrame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
measure: Cortical evoked potentials
timeFrame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
measure: Cortical evoked potentials
timeFrame: During a venipuncture at 2 to 3 days of life in term neonates
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie - Hôpital d'Hautepierre
Study officials:
References: