Trial of Repeated Analgesia With Kangaroo Care - 18 Month Follow-up
TRAKC18
1 other identifier
observational
159
1 country
1
Brief Summary
The primary aim for this study is to determine if maternal Kangaroo Care (KC) provided during painful procedures in early life will mitigate stress release and will improve neurobehavioural outcomes in infants, decrease subsequent pain response, and enhance maternal-child interaction beyond the period of hospitalization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 8, 2017
March 1, 2017
2.8 years
February 24, 2016
March 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Bayley Scales of Infant Development (BSID-III)
The Bayley Scales of Infant and Toddler Development (3rd edition; BSID-III) , the most widely used standardized assessment of early milestone-based development in young children, evaluates five domains related to development of infants from 1 to 42 months of age: cognitive, language, motor, adaptive behaviour, and social-emotional.
18 months corrected postnatal age
Secondary Outcomes (4)
Brief Infant Toddler Social Emotional Assessment (BITSEA)
18 month corrected postnatal age
Early Childhood Behaviour Questionnaire (ECBQ)
18 month corrected postnatal age
Modified Behavioral Pain Scale (MBPS)
2, 6, 12, and 18 months
Measure of Adult and Infant Soothing and Distress Scale (MAISD)
2, 6, 12, and 18 months
Study Arms (1)
Follow-up
No further interventions are planned for this trial and the three pain management interventions from the original study (NCT01561457) will remain our comparison groups (Kangaroo Mother Care alone, Sucrose alone, and Kangaroo Mother Care \& Sucrose). All participants will be invited to back to the IWK Health Centre to receive their Vaccinations at 2, 6, 12 and 18 month time points as well as for their Neurodevelopment assessment at 18 corrected age (BSID-III).
Interventions
Participants will be invited back to IWK Health Centre at time points that correspond to their 2, 6, 12 and 18 month vaccinations and will receive their vaccinations according to Nova Scotia schedule.
During the 18 month follow-up visit, the infants will also undergo neurodevelopmental assessment. Trained medical assessors also blind to original study group assignment will examine the child using the BSID-III Cognitive and Motor Sections. Participants will also be contacted at the infants 18 month corrected postnatal age for the BSIDIII. Parents will be asked to complete the Early Childhood Behaviour Questionnaire and the Brief Infant Toddler Social Emotional Assessment.
Eligibility Criteria
Eligible parents of TRAKC infants who have provided consent will be invited back to an IWK clinic for follow-up visits at a convenient date within +/- 2 weeks of 2, 6, 12 and 18 month CA for their vaccinations as well as at 18 month corrected age for a Bayley Scales of Infant Development (BSID-III).
You may qualify if:
- Participation in the original TRAKC trial (Born less than 36 6/7 weeks gestational age and were stable enough to be held in KC)
- Participants live within 100 km from hospital or are willing to routinely return to the IWK for follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IWK Health Centrelead
- Nova Scotia Health Research Foundationcollaborator
Study Sites (1)
IWK Health Centre
Halifax, Nova Scotia, B3K6R8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marsha Campbell-Yeo, RN, NNP, PhD
IWK Health Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2016
First Posted
February 29, 2016
Study Start
January 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
March 8, 2017
Record last verified: 2017-03