Cerebral hemodynamic response to a therapeutic bed for procedural pain management in preterm infants in the NICU: a randomized controlled trial

Manon Ranger, Arianne Albert, Karon MacLean, Liisa Holsti, Manon Ranger, Arianne Albert, Karon MacLean, Liisa Holsti

Abstract

Introduction: We developed a novel device, Calmer, that mimics key components of skin-to-skin holding to reduce stress in preterm infants. Our feasibility trial showed that Calmer worked 50% better than no treatment and no differently from our standard of care, facilitated tucking (FT), for reducing pain scores during a heel lance in preterm infants in the neonatal intensive care unit.

Objective: We compared the effects of Calmer on regional cerebral hemodynamic activity during a noxious stimulation to FT.

Methods: During a clinically required heel lance, we measured frontal cortex tissue oxygenation in a subsample of 29 preterm infants (27-33 weeks gestational age) from our larger randomized controlled trial. Infants were randomized to either FT (n = 16) or Calmer treatment (n = 12). The outcome measure, obtained using near-infrared spectroscopy, was a change in the tissue oxygenation index (TSI) across study phases (Baseline, Heel Lance, Recovery; median duration 517 seconds [421-906 seconds]).

Results: No statistically significant differences were found between groups in the median TSI during any of the study phases. In response to the heel lance, 7 infants (27.6%) had a TSI that dipped below the 60% threshold (3 in the Calmer group 25% and 4 in the FT group 25%); none below 50%.

Conclusions: Infants on Calmer maintained normal regional cerebral oxygen levels (55%-85%) no differently from infants receiving a human touch intervention during blood collection. Parental skin-to-skin holding is one of the most effective strategies to relieve procedural pain in preterm infants. When parents or FT are not available, Calmer shows potential for filling this gap in care.

Keywords: Cerebral hemodynamic; Near-infrared spectroscopy; Pain; Painful procedure; Prematurity; Skin-to-skin.

Conflict of interest statement

K. MacLean and L. Holsti are inventors of the Calmer medical device for pain management for preterm infants. In partnership with the Provincial Health Services Association of British Columbia, Canada, they could, in the future, receive royalties as a result of licensing agreements made with private industry for commercialization of the device. They have not received any remuneration to date. L. Holsti supervised data collection at arms length; neither authors had access to the data during the study. They had no access during data transfer to the statistician (A. Albert) nor did they conduct the data analysis of the outcome measures reported in this article. The remaining authors have no conflicts of interest to declare. This trial was funded by a grant from the Canadian Institutes of Health Research MOP-133437 (PI: L. Holsti). L. Holsti is supported by a Canadian Institutes of Health Research Canada Research Chair.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Figures

Figure 1.
Figure 1.
Calmer study flow diagram. Patient flow diagram for the general randomized controlled trial, as well as the subsample included in this study. NIRS, near-infrared spectroscopy.
Figure 2.
Figure 2.
Individual NIRS TSI tracings during the 4 study phases for the preterm infants with the TSI below 60%. Continuous tracing of collated measures of the tissue saturation index (TSI in %) through the 4 study phases: baseline 1, baseline 2, heel lance/squeeze procedure, and recovery. 2A-G: individual TSI tracing for the 7 preterm infants (separated by groups) whose TSI dropped ; end of baseline 2: ; first touch laboratory technician: ; heel lance: ; last touch laboratory technician: . TSI, tissue oxygenation index.

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