CompletedNot Applicable

Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.

France50 participantsStarted 2022-04-21

Plain-language summary

The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component). So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.

Who can participate

Age range0 Days – 7 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Variation of the NIPE measures between before and during care.

Timeframe: From 10 minutes before the care to 10 minutes after the beginning of the care

Trial details

NCT IDNCT05223790

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-13

View on ClinicalTrials.gov More Neonatal trials