Status:
UNKNOWN
Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Procedural Pain
Pre-Term
Eligibility:
All Genders
Phase:
NA
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 exp...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 17 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05404594
Start Date
July 17 2019
End Date
April 17 2023
Last Update
January 30 2023
Active Locations (1)
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1
Service de Pédiatrie - Hôpital d'Hautepierre
Strasbourg, France, 67000