Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
Launched by UNIVERSITY HOSPITAL, LILLE · Jan 24, 2022
Trial Information
Current as of June 18, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a tool called the Newborn Infant Parasympathetic Evaluation (NIPE), which helps measure how well an infant's nervous system is working by looking at changes in their heart rate. The goal is to see if this tool can effectively assess pain and discomfort in very premature babies who are being cared for in a neonatal intensive care unit (NICU) while they are on a ventilator and sedated.
To be eligible for this study, babies must be born very prematurely (before 34 weeks of pregnancy) and be 7 days old or younger. They also need to be receiving treatment in the NICU and require sedation and mechanical breathing support. Parents considering participation can expect that their baby's heart rate will be monitored using the NIPE to help determine if it is a good way to understand and measure their pain during critical care. It's important to note that if a baby has certain conditions or if a parent does not wish to participate, they will not be included in the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Infant born very premature before 34 weeks of amenorrhoea + 0 day
- • Age ≤ 7 days
- • Admitted in neonatal reanimation
- • Sedated, intubated, ventilated
- Exclusion Criteria:
- • High frequency oscillation ventilation
- • Heart rate non sinusal
- • Inotropes and atropine
- • Opposition from the guardian of parental authority
- • Difficulty of comprehension or communication making the parental information impossible
About University Hospital, Lille
University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lille, , France
Patients applied
Trial Officials
Riadh Boukris, MD
Principal Investigator
University Hospital, Lille
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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