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

NCT03745963 | Unknown Phase 3

• 1 other identifier: IWKHealthC 1023060
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Infant, Newborn; Electroencephalography

Keywords

Neonate; Pain; Sucrose; Skin-to-skin contact; EEG; Assessment; RCT; Bio behavioural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Premature Infant Pain Profile-Revised

  Composite pain scores with be averaged over 30 second epochs and reported at 30, 60, 90, 120 seconds post heel lance

• 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

• Maternal acceptability: questionnaire

  Immediately post-procedure

Study Arms (2)

Skin-to-skin contact

EXPERIMENTAL

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.

Behavioral: Skin-to-skin contact

24% Oral sucrose

ACTIVE COMPARATOR

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.

Drug: 24% oral sucrose

Interventions

Skin-to-skin contact 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.

Also known as: Kangaroo care (maternal)

Skin-to-skin contact

24% oral sucrose DRUG

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

Also known as: sweet taste

24% Oral sucrose

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IWK Health Centre: lead
• Nova Scotia Health Research Foundation: collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 35725632 DERIVED

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Sucrose; Gurmarin protein, Gymnema sylvestre

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Marsha L Campbell-Yeo, PhD NNP

  School of Nursing, Faculty of Health, Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marsha L Campbell-Yeo, PhD NNP

CONTACT

+1 902 494 4283; marsha.campbell-yeo@dal.ca

Joanne Street

CONTACT

+1 902 470-8888; joanne.street@iwk.nshealth.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dalhousie University School of Nursing, Faculty of Health

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 19, 2018
• Study Start: November 19, 2018
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: November 21, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)