NCT03745963

The Influence of Skin-to-skin Contact on Cortical Activity During Painful Procedures on Preterm Infants in the NICU

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: All
• Age: 32 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Acute
• Infant, Newborn
• Electroencephalography

Interventions

Type	Name	Description
BEHAVIORAL	Skin-to-skin contact	Infants allocated to the SSC arm will be placed in upright, ventral SSC position (holding of a diaper clad baby on the bare chest of a mother) for a minimum of 15 minutes prior to data collection.
DRUG	24% oral sucrose	Administration of 24 percent oral sucrose will occur two minutes prior to the heel lance.

Timeline

• Start date: 2018-11-19
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2018-11-19
• Last updated: 2018-11-21

Locations

1 site across 1 country: Canada