Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants

NCT04911452 | Recruiting DMC

• 1 other identifier: H21-00527
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin care (SSC) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSC; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSC; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff. The goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth and brain development in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased "dose" of Calmer exposure over 2-3 continuous weeks is proposed. 30 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total/day for 2-3 continuous weeks, or to 2-3 weeks of standard NICU care (minimum of 2 and maximum of 3 weeks). Research questions: Trial feasibility Q1. Is it feasible to enrol 30 infants, complete a 2-3-week treatment period (minimum of 2 and maximum of 3 weeks), and measure growth outcomes in preterm infants (26-30 weeks GA) in the NICU in a pilot RCT of daily Calmer treatment versus standard NICU care to inform a larger, definitive RCT? Infant outcomes Q2a. Are there differences in physical growth markers (daily weight gain, head circumference, body length) between preterm infants who receive Calmer and those who receive standard NICU care measured before (baseline) and after 2-3 weeks of daily Calmer exposure? Q2b. Are there differences in brain activity markers, as measured by cerebral electrical (EEG) signalling, between preterm infants who receive Calmer and those who receive standard NICU care, measured during a resting/sleeping state and routine diaper change session at the end of the trial (post 2-3 weeks of daily Calmer exposure)?

Conditions

Prematurity

Keywords

Prematurity; Neonatal intensive care; Growth; Robotic device; Skin-to-skin care; Stress; Brain activity; EEG

Outcome Measures

Primary Outcomes (4)

• Trial feasibility: Consent rates

  Overall average consent rate of infants/month

  48 months

• Trial feasibility: Protocol delivery rate

  Percent of on/off protocol infants for the trial period

  48 months

• Trial feasibility: Complete outcome measures

  Percent of infants with complete clinical primary and secondary outcome measures

  48 months

• Trial feasibility: Safety issues

  Rate of safety issues identified

  48 months

Secondary Outcomes (5)

• Brain activity at rest and during stress event (routine diaper change)

  2-3 weeks

• Weight gain

  2-3 weeks

• Nutritional status

  2-3 weeks

• Head circumference

  2-3 weeks

• Body length

  2-3 weeks

Study Arms (2)

Control

NO INTERVENTION

Standard Neonatal Intensive Care Unit (NICU) care

Calmer

EXPERIMENTAL

Calmer placed and left in infant incubator for a minimum of 2 and maximum of 3 weeks. Calmer treatment provided for minimum total of 3 hours/day (can be discontinuous).

Device: Calmer

Interventions

Calmer DEVICE

Once randomized, infants in the Calmer group will receive treatment for a minimum cumulative total of 3 hours/day during periods when the infant may be too ill to be held or when parents do not wish to hold their infant or are not present. Calmer does not replicate a parent's contact and so the minimum exposure has been tripled. No upper limit of Calmer use will be set. Each day, the research and/or bedside nurse will record the heart and respiratory rates for a two-minute period. The one-minute average will be used to program Calmer for each infant that day to better simulate day-to-day changes in infant-parent contact. The Neonatal Intensive Care Unit (NICU) research nurse will also train the parents/caregivers to self-measure their resting heart and breathing rates so that if they are away from the NICU for more than one day, these values can be sent to the research/ bedside nurse by phone.

Calmer

Eligibility Criteria

• Age: 26 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants admitted to the neonatal intensive care unit (NICU) at the British Columbia (BC) Women's Hospital born at 26-30 completed weeks gestational age (GA). GA is determined accurately using early gestation ultrasonogram (standard of care in BC), or calculated using the last menstrual period;
• Infants who are on continuous positive airway pressure or are ventilated;
• At least one parent/caregiver must speak sufficient English to provide consent

You may not qualify if:

• Infants who have congenital anomalies, small for GA (per medical admission history), or have a history of maternal abuse of controlled drugs and substances; - Infants with an ongoing infection at the time of enrolment;
• Infants that have pre-existing cardiovascular instability defined by shock/hypotension/need for cardiovascular drugs
• Infants receiving paralytic drugs;
• Infants that have major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage/stroke);
• Infants who are beyond the 30th completed week GA (30 weeks + 6 days) at enrolment.

Sponsors & Collaborators

• University of British Columbia: lead
• Women's Health Research Institute of British Columbia: collaborator

Study Sites (1)

British Columbia Women's Hospital and Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

Related Publications (6)

• Johnston C, Campbell-Yeo M, Disher T, Benoit B, Fernandes A, Streiner D, Inglis D, Zee R. Skin-to-skin care for procedural pain in neonates. Cochrane Database Syst Rev. 2017 Feb 16;2(2):CD008435. doi: 10.1002/14651858.CD008435.pub3.

  PMID: 28205208 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Williams N, MacLean K, Guan L, Collet JP, Holsti L. Pilot Testing a Robot for Reducing Pain in Hospitalized Preterm Infants. OTJR (Thorofare N J). 2019 Apr;39(2):108-115. doi: 10.1177/1539449218825436. Epub 2019 Feb 15.

  PMID: 30770034 BACKGROUND

• Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.

  PMID: 23601190 BACKGROUND

• Hauser S, Suto MJ, Holsti L, Ranger M, MacLean KE. Designing and Evaluating Calmer, a Device for Simulating Maternal Skin-to-Skin Holding for Premature Infants. In Proceedings of the 2020 CHI Conference on Human Factors in Computing Systems (CHI '20). 2020. Association for Computing Machinery, New York, NY, USA: 1-15. https://doi.org/10.1145/3313831.3376539

  BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Liisa Holsti, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

• Manon Ranger, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon Ranger, PhD

CONTACT

1-604-827-1382; manon.ranger@ubc.ca

Lindsay Richter, MSc

CONTACT

1-604-875-2000; lindsay.richter@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data outcomes for growth and clinical data will be blind to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-site, single-blind, two-group (treatment and control), randomized pilot trial

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: June 3, 2021
• Study Start: September 27, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)