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

Pain, Acute Clinical Trial

— iCAPmini  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03745963
• Other study ID #: IWKHealthC 1023060
• Status: Recruiting
• Phase: Phase 3
• Start date: November 19, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2018
• Source: IWK Health Centre
• Contact: Marsha L Campbell-Yeo, PhD NNP
• Phone: +1 902 494 4283
• Email: marsha.campbell-yeo[@]dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 36 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Electroencephalography
• Infant, Newborn
• Pain, Acute

Intervention

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.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
IWK Health Centre	Nova Scotia Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-specific event related potential	The primary outcome measure will be pain-specific brain activity measured using a dense array neonatal electroencephalogram (EEG) recording that is time-locked to a medically required heel lance. Infant EEG activity will be recorded from a HydroCel Geodesic Sensor Net positioned according to the modified international 10/20 electrode placement system on a 128 Channel Geodesic EEG SystemTM 400 MR series (Electrical Geodesics Incorporated, Eugene, Oregon, USA). Pain-specific event related potentials will specifically be examined and isolated at electrode sites Cz, as previous research has reported pain-specific activity at this site in both infants and adults.	Isolated within the one-minute window post-procedure at lead CZ
Secondary	Premature Infant Pain Profile-Revised	The PIPP-R, which has been revised from the original PIPP developed 14 years ago, is a 7-indicator composite pain measure consisting of 3 behavioural (facial actions: brow bulge, eye squeeze, and naso-labial furrow), 2 physiological (heart rate, oxygen saturation) and 2 contextual (gestational age, behavioural state) indicators of acute pain. A numerical score ranging from 0 - 3 is assigned to each indicator for a maximum score of 18 reflecting the worst possible pain in infants born at greater than 36 weeks' gestational age. A score of 6 or less is considered to indicate minimal or no pain, a score of 6 to 12 indicates mild or moderate pain, and a score of 12 or greater indicates moderate to severe pain.	Composite pain scores with be averaged over 30 second epochs and reported at 30, 60, 90, 120 seconds post heel lance
Secondary	Recovery	Time to recovery will be considered the amount of time in seconds that elapses until the infant's heart rate returns to baseline average values. The point at which the infant's heart rate reaches baseline levels and is sustained for no less than five to seven beats following the heel lance will indicate recovery.	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
Secondary	Maternal acceptability: questionnaire	Mothers will be asked to complete an open-ended questionnaire with 3-5 questions (depending on assigned condition) following completion of the study procedures. This questionnaire will focus on assessing maternal acceptability of the use of the assigned skin to skin contact or sweet taste intervention as well as the use of neurocognitive imaging technology to measure newborn pain responding in the neonatal period.	Immediately post-procedure