Caring for Babies During the Newborn Screening Blood Test

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: BSweet2Babies video

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Investigators: Principal Investigator: Denise Harrison, RN, PhD, Children's Hospital of Eastern Ontario

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Infant; Breastfeeding; Neonate; Knowledge translation; Sucrose; Blood test; Newborn screening; Skin to skin care
• Other Study ID Numbers: 15/176X