CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
BSweet2Babies videobehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02608892
NCT02608892N/ACompleted

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

Children's Hospital of Eastern Ontario·interventional·Posted Nov 20, 2015·Updated Mar 27, 2019

In Brief

A clinical study evaluating BSweet2Babies video for Pain. Completed, enrolled 100 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 20, 2015
Enrollment StartMay 1, 2016
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.6 years ago

Interventions

BSweet2Babies videobehavioral

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