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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
80
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.
Service de Pédiatrie - Hôpital d'Hautepierre
Strasbourg, France
RECRUITINGThe 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).
Time frame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
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).
Time frame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
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).
Time frame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
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).
Time frame: During a venipuncture at 2 to 3 days of life in term neonates
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
Time frame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
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
Time frame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
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
Time frame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
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
Time frame: During a venipuncture at 2 to 3 days of life in term neonates
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).
Time frame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
Analysis of the impact on the responses of maternal separation
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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
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).
Time frame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
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).
Time frame: During a venipuncture at 2 to 3 days of life in term neonates
Comparison of the response profiles according to the sex
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
Comparison of the response profiles according to the sex
Comparison of the response profiles obtained in females and males
Time frame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Comparison of the response profiles according to the sex
Comparison of the response profiles obtained in females and males
Time frame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Comparison of the response profiles according to the sex
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
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.
Time frame: During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI
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.
Time frame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
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.
Time frame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
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.
Time frame: During a venipuncture at 2 to 3 days of life in term neonates
Correlational analyses by APM group
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
Correlational analyses by APM group
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
Correlational analyses by APM group
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
Correlational analyses by APM group
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
Facial pain behavior
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
Facial pain behavior
Facial pain behavior with the Neonatal Facial Coding System
Time frame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Facial pain behavior
Facial pain behavior with the Neonatal Facial Coding System
Time frame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Facial pain behavior
Facial pain behavior with the Neonatal Facial Coding System
Time frame: During a venipuncture at 2 to 3 days of life in term neonates
Pain index
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
Pain index
Pain index assessing the sympathetic and parasympathetic system
Time frame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Pain index
Pain index assessing the sympathetic and parasympathetic system
Time frame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Pain index
Pain index assessing the sympathetic and parasympathetic system
Time frame: During a venipuncture at 2 to 3 days of life in term neonates
Cortical evoked potentials
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
Cortical evoked potentials
Cortical evoked potentials in Cz according to EEG 10:20 classification
Time frame: During a venipuncture at 34 (+/-2) weeks PMAs in VPI
Cortical evoked potentials
Cortical evoked potentials in Cz according to EEG 10:20 classification
Time frame: During a venipuncture at 40 (+/-2) weeks PMAs in VPI
Cortical evoked potentials
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