RecruitingACTRN12619000404123

The impact of persisting pain following surgery in neonates

The biopsychosocial impact of the persisting need for pain relief in infants following major surgery during the neonatal period: a prospective cohort study with one year follow-up


Sponsor

Macquarie University

Enrollment

138 participants

Start Date

Mar 27, 2019

Study Type

Observational

Conditions

Summary

Clinicians and researchers agree that neonates (infants between 0 and 27 days old following birth) admitted to the neonatal intensive care unit (NICU) experience pain. In addition to being a source of immediate distress and agitation for neonates, pain may also have consequences for neonates during their admission and also extending beyond discharge from the NICU. Researchers have hypothesised that early-life exposure to pain may alter the development of the brain, and thus hinder an infant’s ability to reach age-appropriate developmental milestones. Indeed, acute pain, or procedure-related pain, has been shown to result in long-lasting impacts on developmental outcomes such as brain development (neurodevelopment), growth, and psychosocial functioning. Specifically, researchers have suggested a dose-response relationship between pain in the NICU and poor long-term outcomes. Studies have shown that a greater frequency of painful procedures in the NICU may result in poor cognitive and motor development at eight and 18 months of age, poor cognitive outcomes at school age, increased sensitivity to pain in early childhood, higher rate of internalising behaviours at school age such as fearfulness and social withdrawal, and low weight and head circumference. Furthermore, the impact of painful experiences on the infant’s social wellbeing is unknown. In particular, the role of ongoing pain on the infant-to-parent relationship at such a critical period of relationship formation has not been investigated. Depending on their underlying medical condition, neonates and infants in the NICU undergo a wide range of interventions, some of which may contribute to ongoing pain and distress. It has been difficult to establish whether pain has a direct impact on the developmental trajectory of infants. In order to elucidate whether there is a dose-response relationship between pain experience and developmental outcomes, it is important to determine if there is an impact of the duration of treated pain on the developing infant. The primary objective of this study is to determine whether the persisting need for analgesia, operationalised as the duration of treated pain, during NICU admission has an impact on gross motor skills after discharge. Secondary objectives of this study are to determine whether the duration of treated pain during NICU admission has an impact on 1) other neurodevelopmental outcomes including cognition/problem-solving, fine motor skills, receptive and expressive language, and personal-social skills, 2) complications following surgery, 3) growth, and 4) psychosocial functioning, of the infant.


Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 5 Monthss

Plain Language Summary

Simplified for easier understanding

Babies who require major surgery in their first month of life often experience ongoing pain during their time in a neonatal intensive care unit (NICU). Researchers are growing increasingly concerned about how this early-life pain exposure might affect long-term brain development, growth, and even social functioning. The question being explored in this study is whether the duration of treated pain — not just the number of painful procedures — is linked to development outcomes after the baby goes home. The study will follow infants who had major surgery before 28 days of age through their early development, measuring motor skills, thinking, language, social development, and growth at key timepoints after discharge. Researchers will also look at psychosocial wellbeing and the parent-infant relationship during this critical period. You may be eligible if your baby had at least one major surgery before 28 days of age, was admitted to the NICU, and at least one parent or caregiver is able to understand written and spoken English. Babies whose mothers used significant illicit drugs in pregnancy, or who are known to child protection services, or who require heart-lung bypass surgery are excluded.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This study will be a prospective cohort study with one year follow-up of infants who underwent major surgery before 28 days of age. Major surgery is defined as an open (e.g., gastroschisis) or opening

This study will be a prospective cohort study with one year follow-up of infants who underwent major surgery before 28 days of age. Major surgery is defined as an open (e.g., gastroschisis) or opening of a major body cavity including the head, thorax, and abdomen. The exposure the study is interested in is the impact of the persisting need for analgesia, operationalised as the duration of treated pain, during NICU admission. Pain in the infant will be measured using the Modified Pain Assessment Tool as well as the Echelle Douleur Inconfort Nouveau-ne (English version called the EDIN or Newborn Pain Scale). Details about infants' analgesia requirements will also be gathered during their admission in the NICU.


Locations(1)

The Children's Hospital at Westmead - Westmead

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12619000404123