Clinical trial NCT01433588: The Calmer Project
Official title: Calmer: A Novel Approach for Treating Infant Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Keywords: Managing infant pain
27 - 36+6 weeks gestation
Preterm infants
Lead sponsor: Children's & Women's Health Centre of British Columbia
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 54
Sex: ALL
Minimum age (years): 27
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Behavioral Indicators of Infant Pain (BIIP) Score
timeFrame: During the assessment period in the study, estimated to occur around one hour.
Secondary outcomes:
measure: Secondary Outcome Measures: Heart Rate
timeFrame: During and after the assessment period in the study, estimated to be 6 hours.
measure: Secondary Outcome Measures: Heart Rate Variability
timeFrame: During and after assessment period in the study, estimated to be 6 hours.
measure: Secondary Outcome Measures: NIRS
timeFrame: During the assessment period in the study, estimated to occur over less than an hour.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's and Women's Health Centre
state: British Columbia
Study officials:
affiliation: Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC
name: Liisa Holsti, PhD
role: PRINCIPAL_INVESTIGATOR
References: