NCT02608892

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 27, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

November 11, 2015

Results QC Date

May 15, 2018

Last Update Submit

March 26, 2019

Conditions

Pain

Keywords

BreastfeedingSkin to skin careSucroseNewborn screeningBlood testNeonateInfantKnowledge translation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future Procedures

    Within 24 hours after viewing video intervention

  • Proportion of Parents Who Intend to Recommend the Video to Other Parents

    Within 24 hours after viewing video intervention

  • Proportion of Parents Who Perceive the Duration of the Video as Acceptable

    Within 24 hours after viewing video intervention

Study Arms (2)

Intervention

EXPERIMENTAL

BSweet2Babies video

Behavioral: BSweet2Babies video

Control

NO INTERVENTION

Usual care

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainBreast Feeding

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Results Point of Contact

Title
Dr Denise Harrison
Organization
Children's Hospital of Eastern Ontario
dharrison@cheo.on.ca
613-737-7600

Study Officials

  • Denise Harrison, RN, PhD

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair in Nursing Care of Children, Youth and Families

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 20, 2015

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 27, 2019

Results First Posted

March 27, 2019

Record last verified: 2019-03