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Caring for Babies During the Newborn Screening Blood Test

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ClinicalTrials.gov Identifier: NCT02608892
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Denise Harrison, Children's Hospital of Eastern Ontario

Brief Summary:
Newborn infants have blood work procedures in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving sweet solutions (sucrose or glucose) has been shown to be effective for reducing babies' pain. However, recent studies of neonatal pain management practices demonstrate infrequent use of these strategies. There is a need for parent-targeted interventions, to support parents' involvement in comforting their infants during painful procedures. This pilot RCT will inform all aspects of a full-scale trial and will evaluate the effectiveness of the BSweet2Babies video when shown to parents of newborns prior to newborn screening, on subsequent use of effective pain reduction strategies during the newborn screening blood test. The participants will be randomized to either the control group (usual care), or to the intervention group and will be shown the brief BSweet2Babies video on caring for infants during blood work. The intervention group will be asked to complete a second survey after viewing the video. To evaluate the use of BF, SSC, or sucrose during newborn screening, the research assistant will collect data from the electronic medical record.

Condition or disease Intervention/treatment Phase
Pain Behavioral: BSweet2Babies video Not Applicable

Detailed Description:

Background: Newborn infants have blood work procedures for screening and medical monitoring 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 in newborn infants during painful procedures. However, recent studies of neonatal pain management practices demonstrate infrequent 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 shows parents the effectiveness of BF, SSC, and sucrose during infant bloodwork and how they can use and advocate for these pain treatment strategies.

Objectives: To conduct a pilot randomized controlled trial (RCT) that will inform all aspects of a full-scale trial of the parent-targeted BSweet2Babies knowledge to action (KTA) intervention. The objective of the full scale trial will be to evaluate the effectiveness of the BSweet2Babies video when shown to parents of newborns prior to newborn screening, on subsequent use of effective pain reduction strategies during the newborn screening blood test.

Study design and methods: This study is a pilot 2-armed RCT that will enroll 100 parents in the mother baby unit at The Ottawa Hospital. Following consent, the research assistant will randomize parents to one of two groups: the intervention group (viewing the BSweet2Babies video prior to their baby's newborn screening blood test) or the control group (no intervention). Parents in both groups will complete a brief baseline survey to establish previous knowledge and use of pain management strategies. Participants in the intervention group will subsequently view the 5 minute BSweet2Babies video. Lastly, participants in the intervention group will be asked to complete a second online survey after viewing the video. To evaluate the use of BF, SSC or sucrose during newborn screening, the study research assistant will collect the data from the baby's electronic medical record.

Outcome Measures: The primary outcome is the use of BF, SSC or sucrose during newborn screening measured using data from the electronic medical records. The secondary outcomes are: i) feasibility of recruiting parents and showing the video prior to the infants' newborn screening; ii) effectiveness (i.e. did the video influence intent to use/advocate for one of the strategies); iii acceptability (i.e. would they recommend the video to other parents and suggested improvements to the video). The secondary outcomes will be measured with the online survey.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: Caring for Babies During the Newborn Screening Blood Test: How do Parents Help? A Pilot RCT
Actual Study Start Date : May 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
BSweet2Babies video
Behavioral: BSweet2Babies video
Mothers (and partners if possible) will view the brief BSweet2Babies video on electronic notebooks in French or English, as per parent/s' preference.

No Intervention: Control
Usual care



Primary Outcome Measures :
  1. Pain Management Used During Newborn Screening Blood Test [ Time Frame: Within 48 hours of viewing video intervention ]
    Use of any pain management: breastfeeding or skin to skin care or sucrose


Secondary Outcome Measures :
  1. The Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future Procedures [ Time Frame: Within 24 hours after viewing video intervention ]
    Parents who viewed the intervention video will be asked one survey question about if they intend to use or advocate for breastfeeding, skin to skin care and/or sucrose during future procedures (yes/no)

  2. Proportion of Parents Who Intend to Recommend the Video to Other Parents [ Time Frame: Within 24 hours after viewing video intervention ]
    Parents who viewed the intervention video will be asked one survey question about if they intend to recommend the video to other parents (yes/no)

  3. Proportion of Parents Who Perceive the Duration of the Video as Acceptable [ Time Frame: Within 24 hours after viewing video intervention ]
    Parents who viewed the intervention video will answer one survey question about their perception of whether the 5-minute video was of appropriate duration (too long/too short/just right)



Information from the National Library of Medicine

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

Inclusion Criteria:

  • admitted to the mother baby unit;
  • understands English or French, and
  • their infant is eligible to receive breastfeeding, skin to skin care, or sucrose during newborn screening.

Exclusion Criteria:

- N/A


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): NCT02608892


Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Investigators
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Principal Investigator: Denise Harrison, RN, PhD Children's Hospital of Eastern Ontario

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Responsible Party: Denise Harrison, Chair in Nursing Care of Children, Youth and Families, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02608892    
Other Study ID Numbers: 15/176X
First Posted: November 20, 2015    Key Record Dates
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019
Last Verified: March 2019
Keywords provided by Denise Harrison, Children's Hospital of Eastern Ontario:
Breastfeeding
Skin to skin care
Sucrose
Newborn screening
Blood test
Neonate
Infant
Knowledge translation