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Caring for Babies During the Newborn Screening Blood Test

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608892
Enrollment
100
Registered
2015-11-20
Start date
2016-05-31
Completion date
2016-08-31
Last updated
2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Breastfeeding, Skin to skin care, Sucrose, Newborn screening, Blood test, Neonate, Infant, Knowledge translation

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.

Detailed description

Background: Newborn infants have blood work procedures for screening and medical monitoring in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or glucose) with or without a pacifier, effectively and safely reduce pain in newborn infants during painful procedures. However, recent studies of neonatal pain management practices demonstrate infrequent use of these strategies. There is a clear need for developing and testing acceptable parent-targeted interventions, alongside health care provider-targeted knowledge translation (KT) interventions, to support parents' involvement in comforting their infants during painful procedures. To address this knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the BSweet2Babies video, which shows parents the effectiveness of BF, SSC, and sucrose during infant bloodwork and how they can use and advocate for these pain treatment strategies. Objectives: To conduct a pilot randomized controlled trial (RCT) that will inform all aspects of a full-scale trial of the parent-targeted BSweet2Babies knowledge to action (KTA) intervention. The objective of the full scale trial will be to 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. Study design and methods: This study is a pilot 2-armed RCT that will enroll 100 parents in the mother baby unit at The Ottawa Hospital. Following consent, the research assistant will randomize parents to one of two groups: the intervention group (viewing the BSweet2Babies video prior to their baby's newborn screening blood test) or the control group (no intervention). Parents in both groups will complete a brief baseline survey to establish previous knowledge and use of pain management strategies. Participants in the intervention group will subsequently view the 5 minute BSweet2Babies video. Lastly, participants in the intervention group will be asked to complete a second online survey after viewing the video. To evaluate the use of BF, SSC or sucrose during newborn screening, the study research assistant will collect the data from the baby's electronic medical record. Outcome Measures: The primary outcome is the use of BF, SSC or sucrose during newborn screening measured using data from the electronic medical records. The secondary outcomes are: i) feasibility of recruiting parents and showing the video prior to the infants' newborn screening; ii) effectiveness (i.e. did the video influence intent to use/advocate for one of the strategies); iii acceptability (i.e. would they recommend the video to other parents and suggested improvements to the video). The secondary outcomes will be measured with the online survey.

Interventions

BEHAVIORALBSweet2Babies video

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

Sponsors

Children's Hospital of Eastern Ontario
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Management Used During Newborn Screening Blood TestWithin 48 hours of viewing video interventionUse of any pain management: breastfeeding or skin to skin care or sucrose

Secondary

MeasureTime frameDescription
The Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future ProceduresWithin 24 hours after viewing video interventionParents 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)
Proportion of Parents Who Intend to Recommend the Video to Other ParentsWithin 24 hours after viewing video interventionParents who viewed the intervention video will be asked one survey question about if they intend to recommend the video to other parents (yes/no)
Proportion of Parents Who Perceive the Duration of the Video as AcceptableWithin 24 hours after viewing video interventionParents 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)

Participant flow

Recruitment details

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

Pre-assignment details

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

Participants by arm

ArmCount
Intervention Group
Viewed the BeSweet2Babies video.
51
Control Group
Received usual care.
49
Total100

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up10

Baseline characteristics

CharacteristicIntervention GroupControl GroupTotal
Age, Continuous31.8 years
STANDARD_DEVIATION 5
32.9 years
STANDARD_DEVIATION 6
32.3 years
STANDARD_DEVIATION 5
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
21 Participants23 Participants44 Participants
Sex: Female, Male
Male
30 Participants26 Participants56 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 510 / 49
other
Total, other adverse events
0 / 510 / 49
serious
Total, serious adverse events
0 / 510 / 49

Outcome results

Primary

Pain Management Used During Newborn Screening Blood Test

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

Time frame: Within 48 hours of viewing video intervention

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention GroupPain Management Used During Newborn Screening Blood Test30 Participants
Control GroupPain Management Used During Newborn Screening Blood Test33 Participants
95% CI: [-26.2, 11.5]
Secondary

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

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)

Time frame: Within 24 hours after viewing video intervention

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention GroupProportion of Parents Who Intend to Recommend the Video to Other ParentsYes51 Participants
Intervention GroupProportion of Parents Who Intend to Recommend the Video to Other ParentsNo0 Participants
Secondary

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

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)

Time frame: Within 24 hours after viewing video intervention

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention GroupProportion of Parents Who Perceive the Duration of the Video as AcceptableJust right49 Participants
Intervention GroupProportion of Parents Who Perceive the Duration of the Video as AcceptableToo short0 Participants
Intervention GroupProportion of Parents Who Perceive the Duration of the Video as AcceptableToo long2 Participants
Secondary

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

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)

Time frame: Within 24 hours after viewing video intervention

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention GroupThe Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future ProceduresYes51 Participants
Intervention GroupThe Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future ProceduresNo0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026