Calmer Brains in Very Preterm Infants

Официальное название

Calmer Brains: A Pilot Randomized Trial to Explore Structural and Functional Brain Development in Preterm Infants

Обзор

Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development. Calmer was invented to mimic key parts of parental holding (touch, heartbeat sounds and breathing motion) to help reduce stress if parents cannot be there to hold their infant. Using specialized brain scans done at full term, we will gather initial information in 22 infants born 3-4 months early to compare brain development in infants who receive Calmer at least 3 hours each day (+ regular NICU care) over 2-3 weeks with infants who have regular NICU care.

Подробное описание

Very preterm infants (\< 32 weeks gestational age \[GA\]) experience developmentally unexpected, repeated stress as part of lifesaving care in the NICU during a period of considerable brain maturation and growth. Exposure to early-life stress alters brain maturation resulting in long-term changes in neurodevelopment. Parental skin-to-skin care (SSC) can mitigate stress; however, parents are not always available. Calmer, a patented, therapeutic medical device, was invented to simulate aspects of SSC (skin-like surface, breathing motion, heartbeat sounds) with rates of the latter two individualized for each infant. In a randomized trial, Calmer has been shown to stabilize brain blood flow during a single, routine blood test. Most recently, we found that very preterm infants who received Calmer treatment for 3 continuous weeks had 25% greater head growth compared to controls. However, we do not know if/how Calmer treatment affects brain development in very preterm infants.

Objectives: We will gather pilot data for a larger trial to examine differences in brain structural and functional development in very preterm infants who receive Calmer treatment for 2-3 consecutive weeks compared to controls.

Methods: 22 infants born 26-30 weeks GA admitted to BC Women's Hospital NICU will be randomized to either control (n=11) or treatment groups (n=11; Calmer for 2-3 continuous weeks, 3 hours/day minimum treatment). Infants from both groups will undergo feed and bundle MRI scans at term-equivalent age using high resolution volumetric, diffusion and resting-state functional MRI to explore group differences in whole-brain volumes and structural and functional connectivity. Images will be processed using existing quantitative neonatal imaging analysis pipelines in the Selvanathan and Weber labs at BC Children's Hospital Research Institute. Analyses will include: measures of trial feasibility and description of brain differences between groups.

Significance: Ultimately, Calmer may support healthy brain maturation optimizing the neurodevelopment of vulnerable infants in Canada and beyond.

Вмешательства

• Устройство Calmer
  Calmer, a unique, patented, therapeutic bed that mimics key aspects of SSC that reduce stress in preterm infants. Calmer fits into NICU incubators and cribs, and delivers 3 key SSC stimuli: touch, breathing motion, and heartbeat sounds; the rates of the latter 2 stimuli are individualized to each infant based on their parents' breathing and heart rates. Calmer is designed to provide complementary care only when parents are not able to give SSC. It is not meant nor designed to replace human SSC,

Первичные конечные точки

• Brain Volumes [Срок оценки: When each participant reaches 40 weeks post-conceptual age and return for their MRI scan]
• Brain Functional Connectivity [Срок оценки: When each participant reaches 40 weeks post-conceptual age]
• Brain Fractional Anisotropy [Срок оценки: When participants reach term-equivalent age]

Вторичные конечные точки (2)

• Clinical weight measures [Срок оценки: From the start of study treatment (or enrolment if Control group) to 2-3 weeks later, at the end of intervention exposure.]
• Head growth measures [Срок оценки: From the start of study treatment (or enrolment if Control group) to 2-3 weeks later, at the end of intervention exposure.]

Критерии участия

Критерии включения

• Very preterm infants admitted to the NICU at the BC Women's Hospital

Exclusion Criteria: Infants who have

• Congenital anomalies;
• Born small for GA (per medical admission history);
• History of birthing parent substance use in pregnancy;
• Ongoing infection at the time of enrollment;
• Pre-existing cardiovascular instability defined by shock/hypotension/need for cardiovascular drugs;
• Receiving paralytic drugs;
• Major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage/stroke; VP shunt);
• Beyond the 30th completed week GA (30 weeks + 6 days) at enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• BC Women's Hospital & Health Centre — Vancouver

Публикации

• Holsti L, MacLean K, Oberlander T, Synnes A, Brant R. Calmer: a robot for managing acute pain effectively in preterm infants in the neonatal intensive care unit. Pain Rep. 2019 Mar 14;4(2):e727. doi: 10.1097/PR9.0000000000000727. eCollection 2019 Mar-Apr. PMID 31041426
• Ranger M, Albert A, MacLean K, Holsti L. Cerebral hemodynamic response to a therapeutic bed for procedural pain management in preterm infants in the NICU: a randomized controlled trial. Pain Rep. 2021 Jan 12;6(1):e890. doi: 10.1097/PR9.0000000000000890. eCollection 2021 Jan-Feb. PMID 33490850

Идентификаторы

NCT: NCT07262385 · H25-01015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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