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N/A N=100 Randomized Single-blind Other

Caring for Babies During the Newborn Screening Blood Test

Pain

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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