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

U

University Hospital, Lille

Status

Enrolling

Conditions

Reanimation
Pain Measurement
Neonatal

Treatments

Device: Pain measurement during care procedures in neonatal reanimation

Study type

Observational

Funder types

Other

Identifiers

NCT05223790
2021_0238

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

Under 7 days old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Riadh Boukhris, MD

Data sourced from clinicaltrials.gov

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