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

NCT05404594 | Unknown

• 1 other identifier: 7256
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain; Pre-Term; Venipuncture

Keywords

Very preterm infants; Development of nociception; Cortical hemodynamic responses; Pain indicators; Gender; Maternal voice; Oxytocin

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  During a venipuncture at 2 to 3 days of life in term neonates

Secondary Outcomes (32)

• Comparison of the hemodynamic response profiles and salivary oxytocin levels

  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

  During a venipuncture at 34 (+/-2) weeks PMAs in VPI

• Comparison of the hemodynamic response profiles and salivary oxytocin levels

  During a venipuncture at 40 (+/-2) weeks PMAs in VPI

• Comparison of the hemodynamic response profiles and salivary oxytocin levels

  During a venipuncture at 2 to 3 days of life in term neonates

• Analysis of the impact on the responses of maternal separation

  During a venipuncture (needed for the standard care of the infants) and realized around 30 (+/- 2) weeks PMAs in VPI

Study Arms (2)

Very preterm infant

EXPERIMENTAL

Preterm infant below 33 weeks of GA

Behavioral: Maternal vocal contact

Full term neonate

ACTIVE COMPARATOR

Term neonate from a gestational age of 37 weeks.

Behavioral: Maternal vocal contact

Interventions

Maternal vocal contact BEHAVIORAL

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.

Full term neonate; Very preterm infant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Pédiatrie - Hôpital d'Hautepierre

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Pain, Procedural; Premature Birth; Coitus

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: June 3, 2022
• Study Start: July 17, 2019
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)