Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Effectiveness of Parent-targeted Education (ONesiE)
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|ClinicalTrials.gov Identifier: NCT03099252|
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2017
Last Update Posted : March 28, 2019
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-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 study will evaluate the effectiveness of a parent-targeted and mediated KT strategy, the BSweet2Babies video, when shown to parents of newborns prior to newborn screening or bilirubin testing, on subsequent use of the three pain reduction strategies during the blood test.
The target sample size for the study is 20 hospitals. Following consent, hospitals will be randomized to one of two groups: the intervention group (showing parents the BSweet2Babies video prior to their baby's newborn screening blood test) or the control group (no education or information provided). Hospitals in the intervention group will show 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.
The investigators hypothesize that hospitals randomized to the BSweet2Babies video will have a higher rate of use of BF, SSC or sucrose as measured by the systematically collected Better Outcomes Registry & Network (BORN) Ontario pain data elements during newborn screening or bilirubin testing, compared to hospitals randomized to usual Health Care Provider (HCP)-targeted education.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Parent-targeted BSweet2Babies video Other: HCP-targeted resources||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two-armed cluster RCT. Hospitals in Ontario providing maternal/newborn care are the units of randomization. The intervention is targeted at the 'cluster' (hospital providing maternal/newborn care) and the maternal and newborn care units within the randomized hospitals. The cluster RCT design is appropriate for this project as it minimizes the risk of contamination, which could occur if individual mothers/parent dyads were randomized to different study arms within one organization. Although the video is publicly available for viewing on YouTube, this alone is a passive means of disseminating knowledge and the effect on clinically important outcomes has not been systematically evaluated.|
|Masking:||None (Open Label)|
|Official Title:||Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Effectiveness of Parent-targeted Education (ONesiE)|
|Actual Study Start Date :||October 12, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Intervention Group
Parent-targeted BSweet2Babies video, in addition to 2 HCP-targeted resources
While the hospitals are the "cluster", parents on the mother baby units at each intervention hospital are the participants receiving the intervention (i.e. the video).
Other: Parent-targeted BSweet2Babies video
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.
Other: HCP-targeted resources
Active Comparator: Control Group
2 HCP-targeted resources
Other: HCP-targeted resources
- Patient outcome: Proportion of newborn screening or bilirubin testing where any one of the three effective pain treatments was used. [ Time Frame: 6 months ]These data are systematically collected from all newborns and entered into the BIS along with other BORN Ontario maternal newborn data.
- Patient and Health Services outcome: Number of unsatisfactory newborn screening samples, as systematically collected in the BIS. [ Time Frame: 6 months ]These data are systematically collected from all newborns and entered into the BIS along with other BORN Ontario maternal newborn data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099252
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||Denise Harrison, RN, PhD||Children's Hospital of Eastern Ontario|