N/A
N=100
Caring for Babies During the Newborn Screening Blood Test
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02608892 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Pain Management Used During Newborn Screening Blood Test — 30; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BSweet2Babies video (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Children's Hospital of Eastern Ontario
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Management Used During Newborn Screening Blood Test |
30; 33 | — |
| SECONDARY The Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future Procedures |
51; 0 | — |
| SECONDARY Proportion of Parents Who Intend to Recommend the Video to Other Parents |
51; 0 | — |
| SECONDARY Proportion of Parents Who Perceive the Duration of the Video as Acceptable |
49; 0; 2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02608892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.