Caring for Babies During the Newborn Screening Blood Test

Pain Clinical Trial

Official title:

Caring for Babies During the Newborn Screening Blood Test: How do Parents Help? A Pilot RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608892
• Other study ID #: 15/176X
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: March 2019
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Management Used During Newborn Screening Blood Test	Use of any pain management: breastfeeding or skin to skin care or sucrose	Within 48 hours of viewing video intervention
Secondary	The Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future Procedures	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)	Within 24 hours after viewing video intervention
Secondary	Proportion of Parents Who Intend to Recommend the Video to Other Parents	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)	Within 24 hours after viewing video intervention
Secondary	Proportion of Parents Who Perceive the Duration of the Video as Acceptable	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)	Within 24 hours after viewing video intervention