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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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

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Pain, Acute Infant, Newborn Electroencephalography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Two research assistants (RA1, RA2) who are blinded to the intervention condition will be hired to complete facial coding and calculation of infant PIPP-R scores. Each research assistant will only code data for preterm infants in the skin to skin condition (RA1) or the sucrose condition (RA2) and will not be aware of whether they are watching preterm infant responses to noxious or non-noxious stimulation. To minimize observer bias, research assistants will not be informed of the study design, will not be permitted to attend data collection sessions, and will not share datasets or communicate with the other research assistant regarding the study. During data collection, up close video recording of only the preterm infants face will be completed to attempt to keep coders blind to the nature of the intervention.

Study Groups

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Skin-to-skin contact

Infants will be placed in full ventral skin-to-skin with their mother at least fifteen minutes prior to heel lance to allow time to settle and recover following transfer. Positioning will be determined based on individual maternal preference in order to optimize comfort as well as facilitate ease of access to the infant's foot for blood collection, while also attempting to minimize disruption of continuous EEG, heart rate, oxygen saturation, and video recording. Skin to skin contact will continue until the procedure is completed.

In addition, infants will be offered non-nutritive sucking using a gloved finger or pacifier (based on parental preference) during SSC. Whether infants are actively sucking during the procedure will be recorded by the research coordinator.

Group Type EXPERIMENTAL

Skin-to-skin contact

Intervention Type BEHAVIORAL

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.

24% Oral sucrose

Infants will be placed in a cot or in an incubator, depending on their gestational age, for the duration of the blood collection. Administration of 0.12mls (0.04mls per drop) of 24 percent oral sucrose will occur two minutes prior to the heel lance.

The infants will be offered non-nutritive sucking using a gloved finger or pacifier (based on parental preference) immediately following administration of the complete 24 percent oral sucrose dose. Whether infants are actively sucking during the procedure will be recorded by the research coordinator.

Group Type ACTIVE_COMPARATOR

24% oral sucrose

Intervention Type DRUG

Administration of 24 percent oral sucrose will occur two minutes prior to the heel lance.

Interventions

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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.

Intervention Type BEHAVIORAL

24% oral sucrose

Administration of 24 percent oral sucrose will occur two minutes prior to the heel lance.

Intervention Type DRUG

Other Intervention Names

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Kangaroo care (maternal) sweet taste

Eligibility Criteria

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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)

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No