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Search / Trial NCT05223790

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

Nipe Newborn Infant Parasympathetic Evaluation Pain Measurement Neonatal Care

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.

Locations

Lille, , France

Patients applied

0 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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