Recruiting
Phase 3

Observational Study

Sponsor:

IWK Health Centre

Code:

NCT03745963

Conditions

Pain, Acute

Infant, Newborn

Electroencephalography

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Skin-to-skin contact

24% oral sucrose

Study Details

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

Study ID

NCT03745963

Start date

Nov 19, 2018

Status verified date

Nov, 2018

Completion date

Mar 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

24% oral sucrose

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

Primary outcome measure

  • Pain-specific event related potential [ Time Frame: Isolated within the one-minute window post-procedure at lead CZ ]

Central Contacts and Locations

Central contacts

Marsha L Campbell-Yeo, PhD NNP

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

Joanne Street

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

Locations

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Marsha L Campbell-Yeo, PhD

902-499-0985marsha.campbellyeo@iwk.nshealth.ca

Sarah L Foye, RN

902-470-6704sarah.foye@iwk.nshealth.ca

Principal Investigator:

Marsha L Campbell-Yeo, PhD, NNP

More Information

Sponsor

IWK Health Centre

Last update posted

Nov 21, 2018

Last verified

Nov, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2018-11-21.