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

Primary Purpose

Procedural Pain, Pre-Term, Venipuncture

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Maternal vocal contact
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Procedural Pain focused on measuring Very preterm infants, Development of nociception, Cortical hemodynamic responses, Pain indicators, Gender, Maternal voice, Oxytocin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Service de Pédiatrie - Hôpital d'HautepierreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Very preterm infant

Full term neonate

Arm Description

Preterm infant below 33 weeks of GA

Term neonate from a gestational age of 37 weeks.

Outcomes

Primary Outcome Measures

The cortical hemodynamic response profile
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).
The cortical hemodynamic response profile
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).
The cortical hemodynamic response profile
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).
The cortical hemodynamic response profile
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

Comparison of the hemodynamic response profiles and salivary oxytocin levels
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
Comparison of the hemodynamic response profiles and salivary oxytocin levels
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
Comparison of the hemodynamic response profiles and salivary oxytocin levels
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
Comparison of the hemodynamic response profiles and salivary oxytocin levels
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
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).
Analysis of the impact on the responses of maternal separation
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).
Analysis of the impact on the responses of maternal separation
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).
Analysis of the impact on the responses of maternal separation
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
Comparison of the response profiles obtained in females and males
Comparison of the response profiles according to the sex
Comparison of the response profiles obtained in females and males
Comparison of the response profiles according to the sex
Comparison of the response profiles obtained in females and males
Comparison of the response profiles according to the sex
Comparison of the response profiles obtained in females and males
Comparison of conduction velocities of small caliber nociceptive fibers
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.
Comparison of conduction velocities of small caliber nociceptive fibers
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.
Comparison of conduction velocities of small caliber nociceptive fibers
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.
Comparison of conduction velocities of small caliber nociceptive fibers
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.
Correlational analyses by APM group
Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Correlational analyses by APM group
Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Correlational analyses by APM group
Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Correlational analyses by APM group
Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Facial pain behavior
Facial pain behavior with the Neonatal Facial Coding System
Facial pain behavior
Facial pain behavior with the Neonatal Facial Coding System
Facial pain behavior
Facial pain behavior with the Neonatal Facial Coding System
Facial pain behavior
Facial pain behavior with the Neonatal Facial Coding System
Pain index
Pain index assessing the sympathetic and parasympathetic system
Pain index
Pain index assessing the sympathetic and parasympathetic system
Pain index
Pain index assessing the sympathetic and parasympathetic system
Pain index
Pain index assessing the sympathetic and parasympathetic system
Cortical evoked potentials
Cortical evoked potentials in Cz according to EEG 10:20 classification
Cortical evoked potentials
Cortical evoked potentials in Cz according to EEG 10:20 classification
Cortical evoked potentials
Cortical evoked potentials in Cz according to EEG 10:20 classification
Cortical evoked potentials
Cortical evoked potentials in Cz according to EEG 10:20 classification

Full Information

First Posted
February 21, 2022
Last Updated
January 27, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT05404594
Brief Title
Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
Acronym
NOCI-Prem
Official Title
Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
April 17, 2023 (Anticipated)
Study Completion Date
April 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain, Pre-Term, Venipuncture
Keywords
Very preterm infants, Development of nociception, Cortical hemodynamic responses, Pain indicators, Gender, Maternal voice, Oxytocin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Very preterm infant
Arm Type
Experimental
Arm Description
Preterm infant below 33 weeks of GA
Arm Title
Full term neonate
Arm Type
Active Comparator
Arm Description
Term neonate from a gestational age of 37 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Maternal vocal contact
Intervention Description
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.
Primary Outcome Measure Information:
Title
The cortical hemodynamic response profile
Description
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).
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
The cortical hemodynamic response profile
Description
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).
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
The cortical hemodynamic response profile
Description
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).
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
The cortical hemodynamic response profile
Description
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).
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates
Secondary Outcome Measure Information:
Title
Comparison of the hemodynamic response profiles and salivary oxytocin levels
Description
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
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
Comparison of the hemodynamic response profiles and salivary oxytocin levels
Description
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
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
Comparison of the hemodynamic response profiles and salivary oxytocin levels
Description
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
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
Comparison of the hemodynamic response profiles and salivary oxytocin levels
Description
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
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates
Title
Analysis of the impact on the responses of maternal separation
Description
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).
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
Analysis of the impact on the responses of maternal separation
Description
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).
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
Analysis of the impact on the responses of maternal separation
Description
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).
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
Analysis of the impact on the responses of maternal separation
Description
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).
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates
Title
Comparison of the response profiles according to the sex
Description
Comparison of the response profiles obtained in females and males
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
Comparison of the response profiles according to the sex
Description
Comparison of the response profiles obtained in females and males
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
Comparison of the response profiles according to the sex
Description
Comparison of the response profiles obtained in females and males
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
Comparison of the response profiles according to the sex
Description
Comparison of the response profiles obtained in females and males
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates
Title
Comparison of conduction velocities of small caliber nociceptive fibers
Description
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.
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
Comparison of conduction velocities of small caliber nociceptive fibers
Description
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.
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
Comparison of conduction velocities of small caliber nociceptive fibers
Description
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.
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
Comparison of conduction velocities of small caliber nociceptive fibers
Description
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.
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates
Title
Correlational analyses by APM group
Description
Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
Correlational analyses by APM group
Description
Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
Correlational analyses by APM group
Description
Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
Correlational analyses by APM group
Description
Correlational analyses, by APM group, between the different pain indicators in response to stimulation
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates
Title
Facial pain behavior
Description
Facial pain behavior with the Neonatal Facial Coding System
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
Facial pain behavior
Description
Facial pain behavior with the Neonatal Facial Coding System
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
Facial pain behavior
Description
Facial pain behavior with the Neonatal Facial Coding System
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
Facial pain behavior
Description
Facial pain behavior with the Neonatal Facial Coding System
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates
Title
Pain index
Description
Pain index assessing the sympathetic and parasympathetic system
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
Pain index
Description
Pain index assessing the sympathetic and parasympathetic system
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
Pain index
Description
Pain index assessing the sympathetic and parasympathetic system
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
Pain index
Description
Pain index assessing the sympathetic and parasympathetic system
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates
Title
Cortical evoked potentials
Description
Cortical evoked potentials in Cz according to EEG 10:20 classification
Time Frame
During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Title
Cortical evoked potentials
Description
Cortical evoked potentials in Cz according to EEG 10:20 classification
Time Frame
During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Title
Cortical evoked potentials
Description
Cortical evoked potentials in Cz according to EEG 10:20 classification
Time Frame
During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Title
Cortical evoked potentials
Description
Cortical evoked potentials in Cz according to EEG 10:20 classification
Time Frame
During a venipuncture at 2 to 3 days of life in term neonates

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Service de Pédiatrie - Hôpital d'Hautepierre
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre KUHN, Professor
Phone
03 88 12 77 79
Email
pierre.kuhn@chru-strasbourg.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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