NCT03745963 (iCAPmini) is a Phase 3 clinical trial of Skin-to-skin contact in Pain, Acute, sponsored by IWK Health Centre.

Who is sponsoring NCT03745963?

NCT03745963 is sponsored by IWK Health Centre.

What drugs are being tested in NCT03745963?

Interventions in NCT03745963: Skin-to-skin contact, 24% oral sucrose.

What condition does NCT03745963 study?

NCT03745963 studies Pain, Acute, Infant, Newborn, Electroencephalography.

Is NCT03745963 still recruiting?

NCT03745963 is currently status unknown. Last updated 21 November 2018.

Last reviewed 2018-11-21 · How we verify

NCT03745963: iCAPmini

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 3 Last updated 21 November 2018

What this trial tests

Phase 3 trial testing Skin-to-skin contact in Pain, Acute in 126 participants. Status unknown.

Timeline

19 November 2018

Primary endpoint
31 December 2020

31 March 2021

Quick facts

Lead sponsor	IWK Health Centre
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	126
Start date	19 November 2018
Primary completion	31 December 2020
Estimated completion	31 March 2021
Sites	1 location across Canada

Drugs / interventions tested

Skin-to-skin contact
24% oral sucrose

Conditions studied

Pain, Acute — all drugs for Pain, Acute →
Infant, Newborn — all drugs for Infant, Newborn →
Electroencephalography — all drugs for Electroencephalography →

Sponsor

IWK Health Centre — full company profile →

Who can join

Adults 32 Weeks to 36 Weeks, any sex, with Pain, Acute or Infant, Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Campbell-Yeo M, Benoit B, Newman A, Johnston C, et al · · 2022 · cited 7× · PMID 35725632 · DOI 10.1186/s13063-022-06424-4
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.
Campbell-Yeo M, Benoit B, Newman A, Johnson C, et al · · 2022 · DOI 10.21203/rs.3.rs-1510675/v1

Verify or expand the search:

Other trials of Skin-to-skin contact

Trials testing the same drug.

NCT05503238 — The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants · NA · withdrawn
NCT04967118 — Neonatal Pain Management and Pain Monitoring Using New Methods · NA · unknown

Other recruiting trials for Pain, Acute

Currently open trials in the same condition.

NCT07249827 — A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guid · Phase 2 · recruiting
NCT07053774 — Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain · Phase 2 · recruiting
NCT07009951 — Impact of Virtual Reality in Cardiac Electrophysiology · recruiting
NCT06960317 — Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements · NA · recruiting
NCT06754657 — CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery · Phase 4 · recruiting

Other IWK Health Centre trials

Trials by the same sponsor.

NCT06797076 — App-Based Migraine Treatment: The Health enSuite Study · NA · not yet recruiting
NCT07112430 — Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants · Phase 1, PHASE2 · not yet recruiting
NCT07165782 — Brief Videos Delivered by Text Messages as a Public Health Intervention for PTSD in Youth · NA · recruiting
NCT06968377 — The COVID Dome Trial · NA · not yet recruiting
NCT07284329 — Examining the Efficacy of a Digital Media Intervention to Increase Recruitment Rates · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03745963 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by IWK Health Centre
Last refreshed: 21 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03745963.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing