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ONesiE
Sponsor study identifier
observational
8
1 country
1
Study Start
September 1, 2018
Actual (reported)Primary Completion
March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Newborn infants have blood work procedures for newborn screening and bilirubin testing in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or glucose) with or without a pacifier, effectively and safely reduce pain and distress in newborn infants during painful procedures. However, studies of neonatal pain management practices in Ontario and throughout Canada demonstrate inconsistent use of these strategies. There is a clear need for developing and testing acceptable parent-targeted interventions, alongside health care provider (HCP)-targeted knowledge translation (KT) interventions, to support parents' involvement in comforting their infants during painful procedures. To address this knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the BSweet2Babies video, which demonstrates the effectiveness of BF, SSC, and sucrose during infant bloodwork and how parents can use and advocate for these pain management strategies. This project addresses a knowledge to practice gap that is highly relevant to all babies and their families. Thus, this study has the potential to advance health care of all babies and contribute to the science of KT by evaluating the implementation of a parent-targeted and mediated KT strategy in diverse hospital settings. Hospitals were eligible for inclusion if they (1) provide Level 1 or Level 2 maternal/newborn care contributing data to the Better Outcomes Registry \& Network Ontario (BORN) Information Systems (BIS); (2) have a birth volume of at least 50 per year; (3) have \<85% use of pain management (BF,SSC, sucrose) during newborn screening or bilirubin sampling, as per BIS data; and (4) have \< 50% missing data for the pain management data element in the BIS. Participating hospitals will receive a tablet and will offer all parents the 5 minute BSweet2Babies video before newborn bloodwork. BORN Information System (BIS) data will subsequently be analyzed to evaluate the use of BF, SSC and sweet solutions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2017
Actual (reported)April 4, 2017
Actual (reported)September 1, 2018
Actual (reported)March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Process Evaluation
Directed content analysis will be used to analyze data from monthly interview, bi-monthly teleconferences and end of intervention surveys
7 months.
BORN BIS Pain Data
Number of effective pain treatment used during newborn screening.
Six months prior to study launch date.
BORN BIS Pain Data
Number of effective pain treatment used during newborn screening.
Six months following completion of the intervention.
Participating hospitals will offer the video to all parents on their MBU during the 6 month intervention period (using the preferred delivery methods of the hospital and the parents). The video will be available via multiple means to facilitate optimal parental exposure in diverse settings. This will ensure flexibility of the delivery of the intervention, based on preferences of the nominated nurse leaders and their HCP team, families and available resources. All participating maternal/newborn centres will receive the following tools via the designated nurse unit leader of enrolled sites: 1. Parent-targeted BSweet2Babies video 2. Parent cards- Reminder for parents of video, with Quick Response (QR) code of the video 3. BSweet2Babies Poster-visual reminder for parents and HCP's on the enrolled units 4. Monthly support calls for the nursing leaders of the Mother Baby Units (MBU) 5. Bi-monthly community of practice teleconferences for the nursing leaders of the MBU
The video portrays three babies having blood tests while being i) BF, ii) held SSC with the mother, and iii) receiving sucrose. The calming effects of these strategies are powerfully portrayed. Voice-over in user-friendly language explains how parents can help their babies by partnering with clinicians to use these strategies. As per the definition of patient-targeted and mediated interventions, this video is: i) patient (parent)-targeted, as it actively engages parents to improve their knowledge, positively affect their experience (during newborn screening), change their behavior and their baby's outcomes; ii) patient-mediated, as the video enables parents to change health professional behavior.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ontario hospitals that provide Level 1 or Level 2 maternal/newborn care, contributing data to the BORN Information System and meet the eligibility criteria.
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Denise Harrison, RN, PhD
Children's Hospital of Eastern Ontario
8 participants (actual enrollment reported by the registry).
First Submitted
March 28, 2017
First Posted
April 4, 2017
Study Start
September 1, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 11, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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