Status:
RECRUITING
Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Premature Newborns
Eligibility:
All Genders
32-34 years
Phase:
NA
Brief Summary
Extremely premature newborn infants (ELNs) admitted to hospital are exposed to stressful and painful stimuli, and often to maternal separation, which can affect their long-term neurological developmen...
Detailed Description
* Information visit (V0 - 1 day): parents are informed by the clinical research nurse (CRN); * Inclusion visit (V0): inclusion, collection of consent from the 2 holders of parental authority, collecti...
Eligibility Criteria
Inclusion
- Very premature babies born before the gestational age (GA) of 32 weeks of amenorrhoea (SA) whose corrected age (CA) does not exceed 34 SA at the time of their participation.
- NN requiring close biological monitoring by a PV.
- Hospitalised in the NN medicine and intensive care unit at Strasbourg hospital.
- Consent obtained from both holders of parental authority.
- Person covered by a social health insurance scheme.
Exclusion
- Any known malformation affecting one or more organs.
- Cerebral lesions discovered o n cerebral ultrasound (intraventricular haemorrhage grade \> 2, periventricular leukomalacia).
- Unstable clinical state as judged by the investigator and the medical team.
- Transfer to another hospital centre expected before the end of the study period.
- Mother: Minor. Deprived of liberty by judicial or administrative decision. Under legal protection. Severe psychological pathology. Drug addiction. Difficulty understanding and/or reading the language.
- French.
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 7 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06200662
Start Date
February 22 2024
End Date
February 7 2026
Last Update
July 9 2024
Active Locations (1)
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1
Les Hôpitaux Universitaires
Strasbourg, Bas-Rhin, France, 67091