Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance

NCT02764424 | Completed

• 2 other identifiers: 16000081954454
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Several pain scales are now validated for newborns but they are based on one-off measures and hetero assessments often dependent on many factors including the operator. Recent developments in the real time analysis of the cardiac signal under the influence of autonomic control, have led to the development of a new painful stress index. A monitor has recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic Evaluation - in newborns). It is based on the study of the heart rate variability and the variations of the sympathetic and parasympathetic indices to stimuli. The validation of this nociception index has not been validated in a neonatal unit where special attention is paid to pain control. The main purpose of our study is to show the consistency of this NIPE index (adapted to newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children, hospitalized in intensive unit and neonatal intensive care unit from the University Hospital of Saint-Etienne (France). The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care.

Conditions

Premature Birth; Newborn

Keywords

Newborn; Heart Rate Variability (HRV); Analgesic Nociception Index (ANI); Autonomous Nervous System (ANS)

Outcome Measures

Primary Outcomes (1)

• NIPE index

  Newborn Infant Parasympathetic Evaluation (NIPE) index obtained will be compared to the Premature Infant Pain Profile (PIPP) and ("Douleur Aiguë du Nouveau Né" - Newborn Acute Pain (DAN) scores.

  Day 1

Secondary Outcomes (2)

• Orthosympathetic and parasympathetic indices

  Day 1

• Changes in the NIPE index

  Day 1

Study Arms (1)

Preterm or term newborns

Preterm or term newborns, hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care will be included in the study. This painful stress is made in the patient's usual care and is not modified by the protocol. Their stress due to the painful stimuli will be measured with different scales (2 PIPP (Premature Infant Pain Profile) and DAN (Newborn Acute Pain)) and compared with the index obtained with the NIPE (Newborn Infant Parasympathetic Evaluation - MDoloris®).

Device: NIPE (MDoloris®)

Interventions

NIPE (MDoloris®) DEVICE

Each file consists of a simultaneous recording of an electrocardiogram signal according to usual practice (cardiac monitor PHILIPS), coupled with a concomitant registration of NIPE (Newborn Infant Parasympathetic Evaluation - MDoloris®). The electrocardiogram signal, respiration rate, oxygen saturation (SpO2) and NIPE are recorded simultaneously on a computer with a capture card. The other indices of Heart Rate Variability will be analyzed offline.

Also known as: Newborn Infant Parasympathetic Evaluation index

Preterm or term newborns

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates over 26 weeks of Gestational Age and under 3 months hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France) will be eligible. They will have to perform a potentially painful care (for example an administration of substances by intramuscular way) in the usual care context.

You may qualify if:

• Neonates over 26 weeks of Gestational Age, under 3 months, hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France);
• Neonates with a potentially painful move programmed (dextro, administration of substances by intramuscular, arterial/ venipuncture, change nasogastric tube, tracheal aspirates).

You may not qualify if:

• Newborns sedated;
• Newborn with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

• Cremillieux C, Makhlouf A, Pichot V, Trombert B, Patural H. Objective assessment of induced acute pain in neonatology with the Newborn Infant Parasympathetic Evaluation index. Eur J Pain. 2018 Jul;22(6):1071-1079. doi: 10.1002/ejp.1191. Epub 2018 Mar 24.

  PMID: 29369446 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hugues PATURAL, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 6, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)