Recruiting

Kangaroo Care

Sponsor:

IWK Health Centre

Code:

NCT02694692

Conditions

Pain

Development

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Vaccinations at 2, 6, 12 and 18 month

Neurodevelopment assessment at 18 corrected age

Study Details

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.

Conditions

Pain

Development

Study ID

NCT02694692

Start date

Jan, 2015

Status verified date

Mar, 2017

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion criteria from the initial TRAKC trial included major congenital anomalies, receiving narcotics, or surgery.

Study Design

Enrollment

159 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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.

Primary outcome measure

  • Bayley Scales of Infant Development (BSID-III) [ Time Frame: 18 months corrected postnatal age ]

Central Contacts and Locations

Central contacts

Marsha Campbell-Yeo, RN, NNP, PhD

902-470-7455marsha.campbellyeo@iwk.nshealth.ca

Justine Dol, MSc

902-470-6769justine.dol@iwk.nshealth.ca

Locations

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K6R8

Contacts

Marsha Campbell-Yeo, RN, NNP, PhD

902-470-7455marsha.campbellyeo@iwk.nshealth.ca

Justine Dol, MSc

902-470-6769justine.dol@iwk.nshealth.ca

More Information

Sponsor

IWK Health Centre

Last update posted

Mar 8, 2017

Last verified

Mar, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2017-03-08.