Evaluating pain in very premature infants during neonatal care
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
This study is testing a new way to measure pain in very premature babies by looking at their heart rate to see if it can help improve their comfort during medical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 0 Days to 7 Days |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT05223790 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the Newborn Infant Parasympathetic Evaluation (NIPE) as a method to measure heart rate variability in very premature infants who are ventilated and sedated in neonatal reanimation. The NIPE provides a score indicating the level of parasympathetic activity, which can help evaluate pain and discomfort during neonatal care procedures. The study aims to validate this method specifically for infants born before 34 weeks of gestation and under 7 days old. By analyzing the heart rate variability, the study seeks to improve pain management in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born very prematurely (before 34 weeks of gestation), aged 7 days or younger, who are admitted to neonatal reanimation and are sedated, intubated, and ventilated.
Not a fit: Patients who may not benefit from this study include those receiving high-frequency oscillation ventilation or those with non-sinusoidal heart rates.
Why it matters
Potential benefit: If successful, this study could enhance pain assessment and management in very premature infants, leading to improved neonatal care outcomes.
How similar studies have performed: While the NIPE method has not been previously validated in this specific population, similar approaches to pain measurement in neonates have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- Hop Jeanne de Flandre Chu Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Riadh Boukris, MD — University Hospital, Lille
- Study coordinator: Riadh Boukhris, MD
- Email: riadh.boukhris@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.