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Behavioural Intervention

Calmer Therapy Bed for Premature Infants

N/A
Recruiting
Led By Liisa Holsti, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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) determined accurately using early gestation ultrasonogram or calculated using the last menstrual period
At least one parent/caregiver must speak sufficient English to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trialwill investigate if Calmer, a prototype therapy bed, can reduce stress and improve brain maturation in preterm infants in the NICU, and if it can help them grow physically better.

Who is the study for?
This trial is for preterm infants in the NICU at BC Women's Hospital, born between 26-30 weeks gestational age. They can be on airway support but must not have major health issues like congenital anomalies, infections at enrolment, neurological injuries, cardiovascular instability or a history of maternal substance abuse.Check my eligibility
What is being tested?
The study tests Calmer—a therapy bed designed to reduce stress and promote growth in preterm babies by mimicking skin-to-skin contact with artificial touch, heartbeat sounds and breathing motion. The trial compares daily use of Calmer for three weeks against standard NICU care to see if it improves physical growth and brain oxygen signaling.See study design
What are the potential side effects?
In an earlier study, infants were safely cared for on Calmer up to six hours in one day without adverse effects. It was well accepted by mothers and staff; however, this larger trial will further assess safety over continuous three-week use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My preterm baby was admitted to NICU at BC Women's Hospital, born at 26-30 weeks.
Select...
My parent or caregiver can speak enough English to give consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Trial feasibility: Complete outcome measures
Trial feasibility: Consent rates
Trial feasibility: Protocol delivery rate
+1 more
Secondary outcome measures
Body length
Brain activity at rest and during stress event (routine diaper change)
Head circumference
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CalmerExperimental Treatment1 Intervention
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).
Group II: ControlActive Control1 Intervention
Standard Neonatal Intensive Care Unit (NICU) care

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,986 Total Patients Enrolled
Women's Health Research Institute of British ColumbiaOTHER
5 Previous Clinical Trials
16,289 Total Patients Enrolled
Liisa Holsti, PhDPrincipal InvestigatorThe University of British Columbia
2 Previous Clinical Trials
67 Total Patients Enrolled

Media Library

Calmer (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04911452 — N/A
Premature Infants Research Study Groups: Control, Calmer
Premature Infants Clinical Trial 2023: Calmer Highlights & Side Effects. Trial Name: NCT04911452 — N/A
Calmer (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04911452 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary aim of this medical research?

"This medical trial's primary outcome, to be evaluated over the course of 12 months, is determining feasibility as assessed by completion of relevant metrics. Secondary objectives include assessing sleep/wake states via Newborn Developmental Care and Assessment Program (NIDCAP) coding in 20 second blocks for a 30-minute window; gauging frontal cerebral tissue oxygenation through near-infrared spectroscopy (NIRS); and measuring weight gain using Fenton Growth charts."

Answered by AI

Are researchers currently accepting enrolment into this trial?

"As indicated on clinicaltrials.gov, the trial is actively accepting patients at this time. The initial posting was made September 27th 2021 and underwent a recent update November 4th 2022."

Answered by AI

Does this medical test admit applicants younger than twenty-five?

"As indicated by the inclusion criteria, this clinical trial is available to patients aged 26 Weeks to 30 Weeks. In addition, there are 199 studies for minors and 79 trials open to senior citizens."

Answered by AI

How many individuals can feasibly be involved in this research?

"Indeed, the information available on clinicaltrials.gov points to this trial being open for recruitment. First posted in September 2021 and most recently updated in November 2022, the study is seeking 20 individuals from 1 medical centre."

Answered by AI

What type of individuals are most suitable to take part in this trial?

"This clinical trial seeks 20 participants who were born premature between 26 and 30 weeks gestational age. These infants must have been admitted to the neonatal intensive care unit at the British Columbia Women's Hospital and be either on continuous positive airway pressure or being ventilated. Gestational age will be established via early gestation ultrasonogram (standard of care in BC) or through calculation using the last menstrual period."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants
Manon Ranger 2021. "Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04911452.
~4 spots leftby Sep 2024
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