Trial Outcomes & Findings for Caring for Babies During the Newborn Screening Blood Test (NCT NCT02608892)

NCT ID: NCT02608892

Last Updated: 2019-03-27

Results Overview

Use of any pain management: breastfeeding or skin to skin care or sucrose

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Within 48 hours of viewing video intervention
• Results posted on: 2019-03-27

Participant Flow

Recruitment took place between May and August 2016, at a mother-baby unit in Ontario, Canada.

No enrolled participants were excluded from the study before assignment to groups.

Participant milestones

Measure	Intervention BSweet2Babies video 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.	Control Usual care
Overall Study STARTED	51	49
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Intervention BSweet2Babies video 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.	Control Usual care
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention Group n=51 Participants Viewed the BeSweet2Babies video.	Control Group n=49 Participants Received usual care.	Total n=100 Participants Total of all reporting groups
Age, Continuous	31.8 years STANDARD_DEVIATION 5 • n=51 Participants	32.9 years STANDARD_DEVIATION 6 • n=49 Participants	32.3 years STANDARD_DEVIATION 5 • n=100 Participants
Sex: Female, Male Female	21 Participants n=51 Participants	23 Participants n=49 Participants	44 Participants n=100 Participants
Sex: Female, Male Male	30 Participants n=51 Participants	26 Participants n=49 Participants	56 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Within 48 hours of viewing video intervention

Population: One participant was lost to follow-up in the intervention group.

Use of any pain management: breastfeeding or skin to skin care or sucrose

Outcome measures

Measure	Intervention Group n=50 Participants Viewed the BeSweet2Babies video.	Control Group n=49 Participants Received usual care.
Pain Management Used During Newborn Screening Blood Test	30 Participants	33 Participants

SECONDARY outcome

Timeframe: Within 24 hours after viewing video intervention

Population: All 51 participants in the intervention group provided data for this outcome measure.

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)

Outcome measures

Measure	Intervention Group n=51 Participants Viewed the BeSweet2Babies video.	Control Group Received usual care.
The Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future Procedures Yes	51 Participants	—
The Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future Procedures No	0 Participants	—

SECONDARY outcome

Timeframe: Within 24 hours after viewing video intervention

Population: All 51 participants in the intervention group provided data for this outcome measure.

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)

Outcome measures

Measure	Intervention Group n=51 Participants Viewed the BeSweet2Babies video.	Control Group Received usual care.
Proportion of Parents Who Intend to Recommend the Video to Other Parents Yes	51 Participants	—
Proportion of Parents Who Intend to Recommend the Video to Other Parents No	0 Participants	—

SECONDARY outcome

Timeframe: Within 24 hours after viewing video intervention

Population: All 51 participants in the intervention group provided data for this outcome measure.

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)

Outcome measures

Measure	Intervention Group n=51 Participants Viewed the BeSweet2Babies video.	Control Group Received usual care.
Proportion of Parents Who Perceive the Duration of the Video as Acceptable Just right	49 Participants	—
Proportion of Parents Who Perceive the Duration of the Video as Acceptable Too short	0 Participants	—
Proportion of Parents Who Perceive the Duration of the Video as Acceptable Too long	2 Participants	—

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Denise Harrison

Children's Hospital of Eastern Ontario

Phone: 613-737-7600

Email: dharrison@cheo.on.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place