None listed
Conditions
Brief summary
Recently, a monitor called the Newborn Infant Parasympathetic Evaluation (NIPE) has been used to study pain in children under 2 years of age, as it assigns a numeric value to the pain response. It does this by analysing the variability of the heart rate, and studies have shown that it accurately tells us when the child is reacting to pain during surgery. Newborn babies undergo a range of painful procedures while hospitalised, including major surgery and minor procedures. These procedures can be distressing to the child and the child's carers, and thus it is important to ensure that we accurately recognising and treating the pain these can cause. Additionally, some newborns experience a severe condition caused necrotising enterocolitis (NEC), which can be treated by stopping feeds and administering antibiotics. However, in some cases this needs to be escalated to surgery. Our study aims to better understand the pain experienced by children who undergo major surgeries and minor procedures, and to observe what causes and helps their pain. Additionally, our study aims to investigate whether babies with NEC who experience more pain are more likely to progress to requiring surgery to treat their condition.
Interventions
The Newborn Infant Parasympathetic Evaluation (NIPETM, MDoloris Medical Systems. Loos, France) monitor was developed to overcome these limitations of current pain assessment methods and is validated for the objective assessment for pain in children under 2 years of age.(1) The technology was designed based on the physiological response to pain, specifically the principle that exposure to a painful stimulus causes suppression of the parasympathetic nervous system (PNS). It analyses high frequency
The Newborn Infant Parasympathetic Evaluation (NIPETM, MDoloris Medical Systems. Loos, France) monitor was developed to overcome these limitations of current pain assessment methods and is validated for the objective assessment for pain in children under 2 years of age.(1) The technology was designed based on the physiological response to pain, specifically the principle that exposure to a painful stimulus causes suppression of the parasympathetic nervous system (PNS). It analyses high frequency (0.15-0.40Hz) heart rate variability (HRV) as a measure of PNS tone and provides an objective NIPE index from 0 to 100, with higher indices reflecting lower levels of pain and lower indices reflecting higher levels of pain. NIPE indices of <50 indicate severe pain. The monitor is non-invasive and presents a continuous pain index by analysis of an electrocardiogram signal through connection to the cardiac monitor. The NIPE will be administered during surgery and for up to 24 hours after surgery in the surgical cohort; for up to 5 minutes before, throughout the duration of, and up to 20 minutes after a minor procedure in the minor procedure cohort; and for up to 5 days in the NEC cohort. The monitor will be set up and operated by a member of the research team. No strategies will be used to assess adherence, as the monitor is used to assess pain outcomes, and the impacts of the monitor itself are not an outcome. References: 1. Butruille L, De jonckheere J, Marcilly R, Boog C, Bras da Costa S, Rakza T, et al. Development of a pain monitoring device focused on newborn infant applications: The NeoDoloris project. IRBM. 2015;36(2):80-5.
Sponsors
Monash Children's Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
Participants will include neonates (less than or equal to 28 days of corrected age/ 54 weeks postmenstrual age) receiving Paediatric Surgical or Neonatal care, recruited in one of 3 cohorts: 1. Surgical Cohort: Neonates undergoing surgical procedures, commonly performed under Paediatric Surgical care which may occur in the ward (for example, ward-based reduction of gastroschisis) or in the operating theatre. Surgical procedures include but are not limited to the following; • Upper Gastrointestinal o Pyloric stenosis o Duodenal atresia o Jejunal atresia o Oesophageal atresia o Tracheoesophageal fistula o Congenital diaphragmatic hernia o Malrotation and volvulus • Lower Gastrointestinal o Hirschsprung’s disease o Bowel obstruction o Imperforate anus o Intussusception • Other Surgical Conditions, including but not limited to: o Gastroschisis o Other surgeries that involve opening a body cavity 2. Minor Procedure Cohort: Neonates undergoing minor ward-based procedures in the NICU, including but not limited to: • Heel prick • Venepuncture • Nasogastric tube insertion • Urinary bladder catheterisation • Retinopathy of prematurity assessment of treatment 3. Necrotising Enterocolitis Cohort: Neonates undergoing treatment for necrotising enterocolitis
Exclusion criteria
Children over 28 days corrected age Neonates with significant cardiac, respiratory, or neurological comorbidities (for example, non-sinus cardiac rhythm, respiratory distress syndrome, hypoxic ischaemic encephalopathy)
Outcome results
None listed