Acute PainNCT01433588
The Calmer Project
A study testing The Calmer in people with Acute Pain, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to see if the Calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit. Read more about this study
- Who is it for?
- Ages 27 to 36 weeks
- Conditions the study is for
- Acute Pain
- What is being tested?
- The Calmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Stable infants admitted to the Neonatal Intensive Care Unit at Children's and Women's Health Centre of British Columbia (C\&W)
- Preterm infants born at 27 to 36+6 completed weeks gestational age (GA) will be included
- GA is determined on the basis of the first day of the last menstrual period, early gestation ultrasonogram (in most cases) or best estimate based on neonatal examination
- Mothers must speak enough English to provide consent
Who cannot join
- Infants who have congenital anomalies, active, ongoing infection, or have undergone surgery
- Infants who have received pharmacological analgesics or sedatives within 72 hours of the assessment
- History of maternal abuse of controlled drugs and substances; blood collection that occurs beyond the 35th completed week (35 weeks + 6 days) GA
- Small for GA defined as a birth weight at least 2 standard deviations below mean for GA
- Higher order multiples (e.g. triplets)
- Infants in a cot
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's and Women's Health Centre
Vancouver, British Columbia, V6H3V4
About this study
Official title: Calmer: A Novel Approach for Treating Infant Pain
The purpose of this study is to see if the Calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit.
Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain scores and lower heart rates, and more stable autonomic regulation as measured by heart rate variability indices, than infants given a soother plus facilitated tucking (standard of care) during routine blood collection.
Read the detailed description
60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
- Conditions
- Acute Pain
- Being tested
- The Calmer, Standard of Care
- Keywords
- Managing infant pain, 27 - 36+6 weeks gestation, Preterm infants
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The CalmerDevice
This platform, called the Calmer, interacts with the infant to help reduce stress to help promote better outcomes. Infants can be placed on it for care to mimic Kangaroo Care, maternal skin to skin.
Standard of CareOther
Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
| Study group | Role | What they receive |
|---|---|---|
| Calmer | Active comparator | This therapeutic platform, called the Calmer interacts with the infant to help reduce stress to help promote better outcomes. It is being tested to see if it mimics Kangaroo care, maternal skin to skin, to help promote better health outcomes. Infants would be placed on it prior, during and after bloodwork to see if it elicits a favorable response. Receives: Device: The Calmer |
| Standard Care | Placebo comparator | Standard of care during bloodwork is receiving a soother and facilitated tucking. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral Indicators of Infant Pain (BIIP) Score
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
Measured: During the assessment period in the study, estimated to occur around one hour.
Secondary outcomes (3)
Secondary Outcome Measures: Heart Rate
Heart rate will be recorded during the assessment period, one hour, to denote changes. Additionally, the heart rate will be recorded after the assessment period, for approximately 5 hours.
Measured: During and after the assessment period in the study, estimated to be 6 hours.
Secondary Outcome Measures: Heart Rate Variability
Heart rate variability during the assessment period will be recorded, monitored and reviewed for changes, estimated to occur over the course of an hour. Additionally, the heart rate variability will be recorded after the assessment period, for approximately 5 hours.
Measured: During and after assessment period in the study, estimated to be 6 hours.
Secondary Outcome Measures: NIRS
Brain blood oxy- and de-oxyhemoglobin, TSI, total hemoglobin, using near infra-red spectroscopy. During the assessment period in the study, estimated to occur around one hour.
Measured: During the assessment period in the study, estimated to occur over less than an hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startOct 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's & Women's Health Centre of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liisa Holsti, Children's & Women's Health Centre of British Columbia
- Investigators
- Liisa Holsti, PhD, Principal investigator, Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433588
- Sponsor's protocol ID
- CALMERP
- Status last verified
- Jul 2018
- First submitted
- 9 Sep 2011
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calmer: A Novel Approach for Treating Infant Pain
- ClinicalTrials.gov ID
- NCT01433588
- Acronym / sponsor ID
- CALMERP
- Conditions
- Acute Pain
- Keywords
- Managing infant pain, 27 - 36+6 weeks gestation, Preterm infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Children's & Women's Health Centre of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the Calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit.
Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain scores and lower heart rates, and more stable autonomic regulation as measured by heart rate variability indices, than infants given a soother plus facilitated tucking (standard of care) during routine blood collection.
Detailed description
60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calmer | Active comparator | Device: The CalmerThis therapeutic platform, called the Calmer interacts with the infant to help reduce stress to help promote better outcomes. It is being tested to see if it mimics Kangaroo care, maternal skin to skin, to help promote better health outcomes. Infants would be placed on it prior, during and after bloodwork to see if it elicits a favorable response. |
| Standard Care | Placebo comparator | Other: Standard of CareStandard of care during bloodwork is receiving a soother and facilitated tucking. |
Who may qualify
- Ages
- 27 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Stable infants admitted to the Neonatal Intensive Care Unit at Children's and Women's Health Centre of British Columbia (C\&W)
- Preterm infants born at 27 to 36+6 completed weeks gestational age (GA) will be included
- GA is determined on the basis of the first day of the last menstrual period, early gestation ultrasonogram (in most cases) or best estimate based on neonatal examination
- Mothers must speak enough English to provide consent
Key exclusion criteria (6 listed)
- Infants who have congenital anomalies, active, ongoing infection, or have undergone surgery
- Infants who have received pharmacological analgesics or sedatives within 72 hours of the assessment
- History of maternal abuse of controlled drugs and substances; blood collection that occurs beyond the 35th completed week (35 weeks + 6 days) GA
- Small for GA defined as a birth weight at least 2 standard deviations below mean for GA
- Higher order multiples (e.g. triplets)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The CalmerThis platform, called the Calmer, interacts with the infant to help reduce stress to help promote better outcomes. Infants can be placed on it for care to mimic Kangaroo Care, maternal skin to skin. | Device | Calmer |
| Standard of CareInfant would receive the standard of care for bloodwork, provided a soother and facilitated tucking. | Other | Standard Care |
Primary outcome
Change in Behavioral Indicators of Infant Pain (BIIP) Score
Time frame: During the assessment period in the study, estimated to occur around one hour.
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
3 secondary outcomes
Secondary Outcome Measures: Heart Rate
Time frame: During and after the assessment period in the study, estimated to be 6 hours.
Secondary Outcome Measures: Heart Rate Variability
Time frame: During and after assessment period in the study, estimated to be 6 hours.
Secondary Outcome Measures: NIRS
Time frame: During the assessment period in the study, estimated to occur over less than an hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liisa Holsti, PhD principal investigator
Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Calmer in people with Acute Pain, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavioral Indicators of Infant Pain (BIIP) Score (time frame: During the assessment period in the study, estimated to occur around one hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.