Sudden Infant Death SyndromeNCT03070639
Enhancing Safe Sleep Practices of Urban Low-Income Mothers
A study testing Safe Sleep Intervention and Scald Prevention Intervention in people with Sudden Infant Death Syndrome, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Infant Death Syndrome
- What is being tested?
- Safe Sleep Intervention and Scald Prevention Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years of age) or emancipated minor.
- Parent or legal guardian of the child.
- Child is receiving care at the Harriet Lane Clinic.
- Child's primary care provider is participating in the study.
- English-speaking.
- Lives in Baltimore City or Baltimore County.
- Not homeless or not living in a shelter or in an established transitional housing facility.
Who cannot join
- Not an adult or emancipated minor.
- Not the parent or legal guardian of the child.
- Child is not receiving care at the Harriet Lane Clinic.
- Child's primary care provider is not participating in the study.
- Non English-speaker.
- Does not live in Baltimore City or Baltimore County.
- Homeless or living in a shelter or other established transitional housing facility.
Trial locations and contacts
1 site in 1 country.
About this study
The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician anticipatory guidance about safe sleep and identify physician, patient and parent characteristics associated with coverage of the topic at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies (BHB)'s safe sleep campaign messages and services among our study participants.
Read the detailed description
This intervention trial uses a randomized controlled design and will be conducted in the Harriet Lane Clinic. The study conditions are: Standard Care Group (SG), Attention-Matched Control Group that receives a scald burn prevention intervention (CG), and Intervention Group that receives a safe sleep intervention (IG). Parents or legal guardians will be enrolled during the newborn visit (when the baby is approximately 4-7 days old). While waiting to be seen for their 2-week well-child visit, the parent will complete the Baseline Interview and be randomized to SG, IG, or CG. All participants will receive Standard of Care during all of their well-child visits, which will include standard anticipatory guidance delivered by the pediatric resident. The IG and CG interventions will be delivered in the clinic during the 2-week visit after the baseline survey has been completed. The first follow-up will be conducted at the home of the parent after completing the 2-week visit, when the baby is approximately 3-6 weeks old. The second follow-up will be conducted at the home of the parent after the 2-month well-child visit, when the child is approximately 2-4 months of age. Each home visit consists of an interview covering safe sleep and scald topics, an observation of the baby's sleep environment, and testing the water temperature. The 2-week and 2-month well-child visits will be audio-recorded, and parent or legal guardians will be asked to complete a Visit Exit Checklist.
- Conditions
- Sudden Infant Death Syndrome
- Being tested
- Safe Sleep Intervention, Scald Prevention Intervention
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Sleep InterventionBehavioural
A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on the baby's sleep practices. Participant will also receive a free pack'n play, sleep sack, and educational resources on safe sleep.
Scald Prevention InterventionBehavioural
A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on practices regarding scald risks in the home. Participant will also receive a bath thermometer, candy/frying thermometer, and educational resources on scald prevention.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Study Condition | No intervention | The Standard of Care control group will not receive any additional services at the newborn visit. |
| Attention-Matched Control Condition | Active comparator | The Attention-Matched Control Condition will include the Scald Prevention Intervention. Receives: Behavioral: Scald Prevention Intervention |
| Safe Sleep Intervention Condition | Experimental | The Intervention Condition will include the Safe Sleep Intervention. Receives: Behavioral: Safe Sleep Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants
Assessed with a 125-item questionnaire.
Measured: Follow-up #1 (3-6 weeks)
Secondary outcomes (2)
Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home
Assessed with a 45-item questionnaire.
Measured: Follow-up #1 (3-6 weeks)
Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics
Assessed with an 11-item coding sheet and transcription file.
Measured: 2-week well-child visit and 2-month well-child visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startOct 2015
- Primary completionApr 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sudden Infant Death SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Andrea C Gielen, ScD, ScM, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070639
- Sponsor's protocol ID
- HD072821
- Other IDs
- 1R01HD072821-01A1
- Status last verified
- Aug 2017
- First submitted
- 28 Feb 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Burrell TD, McDonald EM, Mahoney P, Musci RJ, Shields W, Gielen A, Solomon BS. Content of Infant Safe Sleep Counseling and Maternal Reported Practices in an Urban Clinic. Acad Pediatr. 2019 Sep-Oct;19(7):801-807. doi: 10.1016/j.acap.2019.06.014. Epub 2019 Jun 26.
PubMed 31254631McDonald EM, Davani A, Price A, Mahoney P, Shields W, Musci RJ, Solomon BS, Stuart EA, Gielen AC. Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. Inj Prev. 2019 Jun;25(3):146-151. doi: 10.1136/injuryprev-2017-042421. Epub 2017 Sep 22.
PubMed 28939661
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Safe Sleep Practices of Urban Low-Income Mothers
- ClinicalTrials.gov ID
- NCT03070639
- Acronym / sponsor ID
- HD072821
- Conditions
- Sudden Infant Death Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician anticipatory guidance about safe sleep and identify physician, patient and parent characteristics associated with coverage of the topic at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies (BHB)'s safe sleep campaign messages and services among our study participants.
Detailed description
This intervention trial uses a randomized controlled design and will be conducted in the Harriet Lane Clinic. The study conditions are: Standard Care Group (SG), Attention-Matched Control Group that receives a scald burn prevention intervention (CG), and Intervention Group that receives a safe sleep intervention (IG). Parents or legal guardians will be enrolled during the newborn visit (when the baby is approximately 4-7 days old). While waiting to be seen for their 2-week well-child visit, the parent will complete the Baseline Interview and be randomized to SG, IG, or CG. All participants will receive Standard of Care during all of their well-child visits, which will include standard anticipatory guidance delivered by the pediatric resident. The IG and CG interventions will be delivered in the clinic during the 2-week visit after the baseline survey has been completed. The first follow-up will be conducted at the home of the parent after completing the 2-week visit, when the baby is approximately 3-6 weeks old. The second follow-up will be conducted at the home of the parent after the 2-month well-child visit, when the child is approximately 2-4 months of age. Each home visit consists of an interview covering safe sleep and scald topics, an observation of the baby's sleep environment, and testing the water temperature. The 2-week and 2-month well-child visits will be audio-recorded, and parent or legal guardians will be asked to complete a Visit Exit Checklist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care Study Condition | No intervention | –The Standard of Care control group will not receive any additional services at the newborn visit. |
| Attention-Matched Control Condition | Active comparator | Behavioral: Scald Prevention InterventionThe Attention-Matched Control Condition will include the Scald Prevention Intervention. |
| Safe Sleep Intervention Condition | Experimental | Behavioral: Safe Sleep InterventionThe Intervention Condition will include the Safe Sleep Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (18 years of age) or emancipated minor.
- Parent or legal guardian of the child.
- Child is receiving care at the Harriet Lane Clinic.
- Child's primary care provider is participating in the study.
- English-speaking.
Key exclusion criteria (7 listed)
- Not an adult or emancipated minor.
- Not the parent or legal guardian of the child.
- Child is not receiving care at the Harriet Lane Clinic.
- Child's primary care provider is not participating in the study.
- Non English-speaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Sleep InterventionA health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on the baby's sleep practices. Participant will also receive a free pack'n play, sleep sack, and educational resources on safe sleep. | Behavioural | Safe Sleep Intervention Condition |
| Scald Prevention InterventionA health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on practices regarding scald risks in the home. Participant will also receive a bath thermometer, candy/frying thermometer, and educational resources on scald prevention. | Behavioural | Attention-Matched Control Condition |
Primary outcome
Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants
Time frame: Follow-up #1 (3-6 weeks)
Assessed with a 125-item questionnaire.
2 secondary outcomes
Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home
Time frame: Follow-up #1 (3-6 weeks)
Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics
Time frame: 2-week well-child visit and 2-month well-child visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 31254631Burrell TD, McDonald EM, Mahoney P, Musci RJ, Shields W, Gielen A, Solomon BS. Content of Infant Safe Sleep Counseling and Maternal Reported Practices in an Urban Clinic. Acad Pediatr. 2019 Sep-Oct;19(7):801-807. doi: 10.1016/j.acap.2019.06.014. Epub 2019 Jun 26.
- Derived from this study: PubMed 28939661McDonald EM, Davani A, Price A, Mahoney P, Shields W, Musci RJ, Solomon BS, Stuart EA, Gielen AC. Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. Inj Prev. 2019 Jun;25(3):146-151. doi: 10.1136/injuryprev-2017-042421. Epub 2017 Sep 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea C Gielen, ScD, ScM principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Sleep Intervention and Scald Prevention Intervention in people with Sudden Infant Death Syndrome, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants (time frame: Follow-up #1 (3-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03070639, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.