Clinical trial NCT03745963: The Influence of Skin-to-skin Contact on Cortical Activity During Painful Procedures on Preterm Infants in the NICU
Official title: iCAP Mini - The Influence of Skin-to-skin Contact on Cortical Activity During Painful Procedures on Preterm Infants in the Neonatal Intensive Care Unit: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Acute
Infant, Newborn
Electroencephalography
Keywords: Neonate
Pain
Sucrose
Skin-to-skin contact
EEG
Assessment
RCT
Bio behavioural
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Research Foundation
First posted: 2018-11-19
Enrollment: 126
Sex: ALL
Minimum age (years): 32
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effect of SSC compared to sucrose on pain induced activity in the preterm infant brain using: a) series of low intensity experimental stimuli (PinPrick);and b) medically required heel lance. Secondary objectives include determining: a) differences between behavioral pain response and pain response during heel lance; and b) rate of adverse events across groups.

Detailed description: Hospitalized preterm infants undergo an average of 12 painful procedures daily, with less than half receiving pain relief. Poorly treated early pain can have long lasting negative effects that impact later learning, development, and reaction to future pain, stress, and emotional experiences. While sweet tasting solution (sucrose) is considered the standard of care for reducing behavioral responses to acute procedural pain in preterm infants, some evidence that sucrose may not similarly reduce pain related brain activity raises concerns regarding the degree of pain relieving effect. This concern is especially relevant as the use of sucrose to manage repeated acute pain has not been found to prevent heightened later pain associated with this exposure. Strong evidence suggests that maternal infant skin-to-skin contact (SSC) is effective in reducing behavioral responses to pain. Given the multi-sensory benefits of SSC, it is highly likely that SSC provided during pain in early life may reduce pain induced brain activity.

Infants ( n=126) (32 to 36 completed weeks gestational age) admitted to the Neonatal Intensive Care Unit, and their mothers within the first seven days of age will be randomly assigned to receive: i) SSC or ii) 24 % oral sucrose. Each baby will receive both the PinPrick and heel lance, following a no treatment baseline period. The primary outcome is pain related brain activity measured using an electroencephalogram (EEG) pain-specific event-related potential. Secondary outcomes include pain intensity measured using a behavioural infant pain assessment tool (Premature Infant Pain Profile-Revised) and rate of adverse events.

This will be the first study to examine the effect of SSC on pain induced brain activity in the preterm infant brain during experimental and clinical pain stimuli, measured using EEG. Given the negative neurodevelopmental outcomes associated with unmanaged pain, it is imperative that preterm infants receive the most effective pain relieving treatments to improve their health outcomes.

Eligibility criteria: Inclusion criteria:

* stable neonates delivered between 32 and 36 completed weeks Gestational age (GA) at birth (Determination of stability will be made in consultation with the attending neonatal staff)
* admitted to NICU
* parents are able to read and write English
* will be approached for inclusion within the first seven days following birth

Exclusion criteria:

* major congenital anomalies
* receiving or received opioids in 24 hours preceding heel lance
* immediate post operative period (\<72 hours) following surgery
* history of hypoxic ischemic encephalopathy requiring cooling
* contraindication for sucrose administration (e.g., unable to swallow, paralysis)

Primary outcomes:
measure: Pain-specific event related potential
timeFrame: Isolated within the one-minute window post-procedure at lead CZ
Secondary outcomes:
measure: Premature Infant Pain Profile-Revised
timeFrame: Composite pain scores with be averaged over 30 second epochs and reported at 30, 60, 90, 120 seconds post heel lance
measure: Recovery
timeFrame: The point at which the preterm infant's heart rate reaches baseline levels and is sustained for no less than five to seven beats following the heel lance, time will vary across patients but will be anticipated to be no longer than 5 minutes
measure: Maternal acceptability: questionnaire
timeFrame: Immediately post-procedure
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: School of Nursing, Faculty of Health, Dalhousie University
name: Marsha L Campbell-Yeo, PhD NNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell-Yeo M, Benoit B, Newman A, Johnston C, Bardouille T, Stevens B, Jiang A. The influence of skin-to-skin contact on Cortical Activity during Painful procedures in preterm infants in the neonatal intensive care unit (iCAP mini): study protocol for a randomized control trial. Trials. 2022 Jun 20;23(1):512. doi: 10.1186/s13063-022-06424-4.