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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02694692
Other study ID # 1017737
Secondary ID
Status Recruiting
Phase N/A
First received February 24, 2016
Last updated March 7, 2017
Start date January 2015
Est. completion date October 2017

Study information

Verified date March 2017
Source IWK Health Centre
Contact Marsha Campbell-Yeo, RN, NNP, PhD
Phone 902-470-7455
Email marsha.campbellyeo@iwk.nshealth.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Vaccinations at 2, 6, 12 and 18 month
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.
Behavioral:
Neurodevelopment assessment at 18 corrected age
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.

Locations

Country Name City State
Canada IWK Health Centre Halifax Nova Scotia

Sponsors (2)

Lead Sponsor Collaborator
IWK Health Centre Nova Scotia Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Brief Infant Toddler Social Emotional Assessment (BITSEA) The BITSEA is the Brief form of the Infant Toddler Social and Emotional Assessment, which covers domains of behaviour. The BITSEA is effective for children aged 12 to 36 months. 18 month corrected postnatal age
Secondary Early Childhood Behaviour Questionnaire (ECBQ) The ECBQ was developed and validated to measure temperament in toddlers between 18 and 36 months of age and has shown adequate levels of reliability and validity. The 201-item parent-report questionnaire assesses 18 dimensions of temperament. 18 month corrected postnatal age
Secondary Modified Behavioral Pain Scale (MBPS) The MBPS, a well-validated acute pain scale used to measure procedural pain, including needle related pain in infant populations, starting at 2 months. The MBPS assesses pain in terms of three observable behaviours: facial expressions, cry, and body movement. 2, 6, 12, and 18 months
Secondary Measure of Adult and Infant Soothing and Distress Scale (MAISD) This is a behavioural measure developed to assess adult and infant behaviour during medical procedures. 2, 6, 12, and 18 months
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