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

Primary Purpose

Prematurity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Calmer
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity focused on measuring Prematurity, Neonatal intensive care, Growth, Robotic device, Skin-to-skin holding, Stress

Eligibility Criteria

26 Weeks - 30 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • British Columbia Women's Hospital and Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Calmer

Arm Description

Standard Neonatal Intensive Care Unit (NICU) care

Calmer placed and left in infant incubator for the 3-week study period. Calmer treatment provided for minimum total of 3 hours/day (can be discontinuous).

Outcomes

Primary Outcome Measures

Trial feasibility: Consent rates
Overall average consent rate of infants/month
Trial feasibility: Protocol delivery rate
Percent of on/off protocol infants for the trial period
Trial feasibility: Complete outcome measures
Percent of infants with complete clinical primary and secondary outcome measures
Trial feasibility: Safety issues
Rate of safety issues identified

Secondary Outcome Measures

Weight gain
The change in average infant weight gain between Calmer and control groups in grams/day (g/d) will be measured on the day before the start of the treatment (baseline), at the mid-way point (~day 11), and at the end of the 3-week period, then divided by the number of treatment days. Sex and gestational age (GA) age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in weight percentiles between baseline and end of treatment will then be calculated.
Nutritional status
Measures of daily feeding and nutritional data will include: method of feeding (intravenous, nasogastric, oral-gastric, oral), type (total parenteral nutrition, breastmilk (mother's or donor), formula, additives (Human milk fortifier, lipids), frequency/timing and method (breast/bottle) of transition from tube to oral feeds at transfer/discharge.
Head circumference
Baseline, mid-point and end-of-treatment measures of head circumference in cm (occipito-frontal circumference [OCP]) will be reported. Sex and GA age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in OFC percentiles between baseline and end of treatment will then be calculated.
Body length
Baseline, mid-point and end-of-treatment measures of body length in cm will be reported. Sex and GA age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in body length percentiles between baseline and end of treatment wil then be calculated.

Full Information

First Posted
May 22, 2021
Last Updated
November 4, 2022
Sponsor
University of British Columbia
Collaborators
Women's Health Research Institute of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04911452
Brief Title
Creating a Calmer NICU: Optimizing Growth and Development in Preterm Infants
Official Title
Creating a CALMER NICU: Pilot Testing a Robot for Optimizing Growth and Development in Preterm Infants in the NICU
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Women's Health Research Institute of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 holding (SSH) 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 SSH; 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 SSH; 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 in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased "dose" of Calmer exposure over 3 continuous weeks is proposed. 20 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 3 continuous weeks, or to 3 weeks of standard NICU care. Research questions: Is it feasible to enrol 20 infants, complete a 3-week treatment period, and have complete data of growth measure outcomes in 17 preterm infants in the NICU in a pilot RCT of daily Calmer treatment versus standard care to inform a larger, definitive RCT? Are there differences in brain oxygen signalling, physical growth markers (e.g. daily weight gain) between groups measured at start of the study and after 3 weeks of daily Calmer exposure?
Detailed Description
Pilot trial implementation targets: Targets for success would be that the informed consent rate will be at least 40%, 20 patients will be enrolled in 18 months, 95% of infants will receive the 3 hour minimum treatment, and patient assessment completion rate will be at least 85%. The results of this pilot trial will be used to inform the design of a larger RCT. The results of this pilot trial will allow to assess patient accrual, protocol adherence, and to monitor the completeness and quality of the outcome data. If implementation targets are met, an application for further funding to use this protocol in a larger, multisite, non-inferiority trial comparing SSH + Calmer to SSH alone will be put forth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Prematurity, Neonatal intensive care, Growth, Robotic device, Skin-to-skin holding, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-site, single-blind, two-group (treatment and control), randomized pilot trial
Masking
Outcomes Assessor
Masking Description
Data outcomes for growth and clinical data will be blind to group allocation
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard Neonatal Intensive Care Unit (NICU) care
Arm Title
Calmer
Arm Type
Experimental
Arm Description
Calmer placed and left in infant incubator for the 3-week study period. Calmer treatment provided for minimum total of 3 hours/day (can be discontinuous).
Intervention Type
Device
Intervention Name(s)
Calmer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trial feasibility: Consent rates
Description
Overall average consent rate of infants/month
Time Frame
12-18 months
Title
Trial feasibility: Protocol delivery rate
Description
Percent of on/off protocol infants for the trial period
Time Frame
12-18 months
Title
Trial feasibility: Complete outcome measures
Description
Percent of infants with complete clinical primary and secondary outcome measures
Time Frame
12-18 months
Title
Trial feasibility: Safety issues
Description
Rate of safety issues identified
Time Frame
12-18 months
Secondary Outcome Measure Information:
Title
Weight gain
Description
The change in average infant weight gain between Calmer and control groups in grams/day (g/d) will be measured on the day before the start of the treatment (baseline), at the mid-way point (~day 11), and at the end of the 3-week period, then divided by the number of treatment days. Sex and gestational age (GA) age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in weight percentiles between baseline and end of treatment will then be calculated.
Time Frame
12-18 months
Title
Nutritional status
Description
Measures of daily feeding and nutritional data will include: method of feeding (intravenous, nasogastric, oral-gastric, oral), type (total parenteral nutrition, breastmilk (mother's or donor), formula, additives (Human milk fortifier, lipids), frequency/timing and method (breast/bottle) of transition from tube to oral feeds at transfer/discharge.
Time Frame
12-18 months
Title
Head circumference
Description
Baseline, mid-point and end-of-treatment measures of head circumference in cm (occipito-frontal circumference [OCP]) will be reported. Sex and GA age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in OFC percentiles between baseline and end of treatment will then be calculated.
Time Frame
12-18 months
Title
Body length
Description
Baseline, mid-point and end-of-treatment measures of body length in cm will be reported. Sex and GA age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in body length percentiles between baseline and end of treatment wil then be calculated.
Time Frame
12-18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Ranger, PhD
Phone
1-604-827-1382
Email
manon.ranger@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Naama Rozen, MSc
Phone
1-604-875-2000
Ext
7408
Email
Naama.Rozen@cw.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liisa Holsti, PhD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manon Ranger, PhD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Women's Hospital and Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon Ranger, PhD
Phone
1-604-827-1382
Email
manon.ranger@ubc.ca
First Name & Middle Initial & Last Name & Degree
Naama Rozen, MSc
Phone
1-604-875-2000
Ext
7408
Email
Naama.Rozen@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Manon Ranger, PhD
First Name & Middle Initial & Last Name & Degree
Liisa Holsti, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28205208
Citation
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.
Results Reference
background
PubMed Identifier
31041426
Citation
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.
Results Reference
background
PubMed Identifier
33490850
Citation
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.
Results Reference
background
PubMed Identifier
30770034
Citation
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.
Results Reference
background
PubMed Identifier
23601190
Citation
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.
Results Reference
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Creating a Calmer NICU: Optimizing Growth and Development in Preterm Infants

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