Clinical trial NCT02694692: Trial of Repeated Analgesia With Kangaroo Care - 18 Month Follow-up
Official title: Trial of Repeated Analgesia With Kangaroo Care - 18 Month Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Development
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Research Foundation
First posted: 2016-02-29
Enrollment: 159
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Detailed description: Background: Infants in the Neonatal Intensive Care Unit receive an average of 7 painful procedures daily yet less than half receive interventions to manage pain. Importantly, there are adverse long-term effects associated with untreated pain. Moreover, the developmental trajectory of an infant born preterm is further compromised by prolonged periods of separation from their mothers during their hospital stay that also impacts mother-infant relationships. Thus, there is a crucial need to minimize procedural pain and associated consequences. Kangaroo Care (KC) is an effective strategy for reducing procedural pain and promoting mother-infant interactions in infants demonstrated in multiple clinical trials and systematic reviews. Not known is the impact of consistent KC for pain on long term outcomes. The primary aim for this study is to determine if maternal 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.

Research Design: Using a randomized clinical trial follow up design, mother-infant dyads taking part in the current CIHR and NSHRF-funded TRAKC trial (randomized to one of three interventions during all routine clinically necessary painful procedures for the duration of their initial neonatal intensive care unit hospital stay (KC/placebo; sucrose alone, considered to be standard care; or KC/ sucrose) will be compared on neurobehavioural outcomes up to 18 months.

Procedure: Eligible mother-infant dyads will be contacted prior to routine 2, 6, 12 and 18 month clinic visits where during these visits, infants will undergo an immunization and naturalistic observations will be recorded. Coders blinded to the study will score pain intensity and maternal comforting behavior using validated measures. At the 18 month visit, trained medical assessors blind to group assignment will perform the primary outcome measure, Bayley Scales of Infant Development (3rd ed) (BSID-III).

Outcomes: The investigators hypothesize that infants from the current TRAKC trial who were assigned to either KC group (alone or in combination with sucrose) when compared to those infants in the sucrose alone group will have: Primary outcome: H1. higher scores on the BSID-III at 18 months corrected postnatal age. Secondary outcomes: H2. higher scores in socio-affective development (Social-Emotional axis of the BSID-III and the Brief Infant Toddler Social Emotional Assessment (BITSEA); H3. lower scores on Negative Affectivity, higher scores on Surgency/Extraversion and Effortful Control as measured by the Early Childhood Behavior Questionnaire (ECBQ); H4. lower pain scores measured using the Modified Behavioral Pain Scale (MBPS) at 2, 6, 12, and 18 month;. H5. higher maternal infant interaction scores measured using Measure of Adult and Infant Soothing and Distress Scale (MAISD) at 2, 6, 12 and 18 months.

Sample size: The sample size is 159 mother-infant dyads at 18 months.

Benefits of the Research Project: New evidence about the long-term impact of early KC provided during early painful procedures is important to the effective management of procedural pain and development in vulnerable infants. By fully integrating mothers and families as active participants, it will have direct implications regarding the improvement of outcomes of at-risk newborns, not only for their immediate physiological stability and later development, but also their families, and the health care system in general.

Eligibility criteria: 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.

Primary outcomes:
measure: Bayley Scales of Infant Development (BSID-III)
timeFrame: 18 months corrected postnatal age
Secondary outcomes:
measure: Brief Infant Toddler Social Emotional Assessment (BITSEA)
timeFrame: 18 month corrected postnatal age
measure: Early Childhood Behaviour Questionnaire (ECBQ)
timeFrame: 18 month corrected postnatal age
measure: Modified Behavioral Pain Scale (MBPS)
timeFrame: 2, 6, 12, and 18 months
measure: Measure of Adult and Infant Soothing and Distress Scale (MAISD)
timeFrame: 2, 6, 12, and 18 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Marsha Campbell-Yeo, RN, NNP, PhD
role: PRINCIPAL_INVESTIGATOR
References: