Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Effectiveness of Parent-targeted Education (ONesiE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03099252
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2017
Last Update Posted : March 28, 2019
Sponsor:
Collaborators:
Ontario Child Health Support Unit (OCHSU)
Better Outcomes Registry & Network Ontario
Dalhousie University
Ottawa Hospital Research Institute
University of Calgary
McGill University
The Hospital for Sick Children
Headwaters Health Care Centre
Champlain Maternal Newborn Regional Program
St Thomas Elgin General Hospital
Baby Friendly Hospital Initiative
Information provided by (Responsible Party):
Denise Harrison, Children's Hospital of Eastern Ontario

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
  1. publically-available poster developed jointly by the study CoPIs and BFI Ontario
  2. the publically-available webinar presented by the CoPIs

Active Comparator: Control Group
2 HCP-targeted resources
Other: HCP-targeted resources
  1. publically-available poster developed jointly by the study CoPIs and BFI Ontario
  2. the publically-available webinar presented by the CoPIs




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for hospitals include:

  • Hospitals providing Level 1 and Level 2 maternal/newborn care contributing data to the BIS
  • A birth volume of at least 50 per year

Hospitals will be excluded if they:

  • Already have >85% use of pain management (BF, SSC, sucrose) during newborn screening or bilirubin sampling, as per BIS data These hospitals will be excluded to avoid a ceiling effect.
  • Have >50% missing data for the pain management data element in the BIS. The primary outcome from this study is based on the pain management data in the BIS and thus sites who are not able to enter this data will be excluded. Fifty percent data entry for this data element as considered sufficient as it shows the site already has some data entry systems already in place for this data element.
  • In addition, two hospitals are excluded (Headwaters Health Care Centre and St Thomas Elgin General Hospital) as they will be our 'model' Level 1 and 2 hospitals. Our health care representatives from these hospitals, Gilmore and McCullough, in collaboration with their local interdisciplinary teams, will advise on all aspects of the delivery of the video to the units and parents, thus optimizing the intervention being delivered as planned (fidelity of the intervention).

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Ontario Child Health Support Unit (OCHSU)
Better Outcomes Registry & Network Ontario
Dalhousie University
Ottawa Hospital Research Institute
University of Calgary
McGill University
The Hospital for Sick Children
Headwaters Health Care Centre
Champlain Maternal Newborn Regional Program
St Thomas Elgin General Hospital
Baby Friendly Hospital Initiative
Investigators
Layout table for investigator information
Principal Investigator: Denise Harrison, RN, PhD Children's Hospital of Eastern Ontario

Layout table for additonal information
Responsible Party: Denise Harrison, Chair in Nursing Care of Children, Youth and Families, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT03099252     History of Changes
Other Study ID Numbers: CHEO REB# 17/01CTO
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No