Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000404123
Acronym
pSPIN
Enrollment
44
Registered
2019-03-13
Start date
2019-03-27
Completion date
2021-12-31
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

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.

Sponsors

Macquarie University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
0 to 5 Months
Healthy volunteers
No

Inclusion criteria

i. Had at least one major surgery less than 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; ii. Were admitted to the neonatal intensive care unit; iii. Have at least one parent/caregiver who is able to understand written and spoken English in order to participate.

Exclusion criteria

i. Are diagnosed with neonatal abstinence syndrome from maternal drug use, or ii. Are known to the Family and Community Services. iii. Neonates who are expected to undergo cardiopulmonary bypass.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026