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

Not Applicable

Recruiting

• Conditions: Procedural Pain; Pre-Term; Venipuncture
• Interventions: Behavioral: Maternal vocal contact

• Registration Number: NCT05404594
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-17
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-30
• Primary Completion: 2023-04-17
• Study Completion: 2023-04-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full term neonate	Maternal vocal contact	Term neonate from a gestational age of 37 weeks.
Very preterm infant	Maternal vocal contact	Preterm infant below 33 weeks of GA

Primary Outcome Measures

Name	Time	Method
The cortical hemodynamic response profile	During a venipuncture 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).

Secondary Outcome Measures

Name	Time	Method
Comparison of the hemodynamic response profiles and salivary oxytocin levels	During a venipuncture at 2 to 3 days of life in term neonates	Comparison of the hemodynamic response profiles and salivary oxytocin levels during 2 consecutive venipunctures, without and with the addition of the maternal voice as a supplementary non-pharmacological pain strategies
Analysis of the impact on the responses of maternal separation	During a venipuncture at 2 to 3 days of life in term neonates	Analysis of the impact on the responses of maternal separation determined by the absence of early skin-to-skin contact (in the VPI \< 3 days of life and in the term newborn \< 2 hours of life).
Comparison of the response profiles according to the sex	During a venipuncture at 2 to 3 days of life in term neonates	Comparison of the response profiles obtained in females and males
Comparison of conduction velocities of small caliber nociceptive fibers	During a venipuncture at 2 to 3 days of life in term neonates	Comparison of conduction velocities of small caliber nociceptive fibers measured by evoked potentials, in response to non-painful cold stimulation in the VPIs of different APMs groups.
Pain index	During a venipuncture at 2 to 3 days of life in term neonates	Pain index assessing the sympathetic and parasympathetic system
Cortical evoked potentials	During a venipuncture at 2 to 3 days of life in term neonates	Cortical evoked potentials in Cz according to EEG 10:20 classification
Correlational analyses by APM group	During a venipuncture at 2 to 3 days of life in term neonates	Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Facial pain behavior	During a venipuncture at 2 to 3 days of life in term neonates	Facial pain behavior with the Neonatal Facial Coding System

Trial Locations

Locations (1)

Service de Pédiatrie - Hôpital d'Hautepierre; 🇫🇷 Strasbourg, France