SIDSNCT03662048
Improving Infant Sleep Safety With the Electronic Health Record
A study testing Safe in people with SIDS and Infant Development, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This research is being done to find out if individualized feedback provided to parents on safe infant sleep can improve safety. This will be accomplished by having parents send photographs of their baby sleeping through the patient portal of the electronic health record (EHR). Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- SIDS, Infant Development
- What is being tested?
- Safe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 11 Sep 2019
- 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age: ≥37 weeks
- Singleton birth
- Newborns ages 0 days to 14 days old
- Newborn nursery stay <=7 days
- English speaking mother
- Mother ≥18 years old
Show all 10Show fewer
- Has email/internet access
- Willing to sign up for the Penn State Health Patient Portal through the Electronic Health Record (EHR)
- Owns a smart phone, digital camera, or tablet that can take pictures to be transmitted through the EHR
- Plan to follow with a Penn State Health Provider though the infant's 3-4 month well child visit
Who cannot join
- Maternal morbidity or pre-existing condition that affects ability to care for the newborn (e.g. narcotic drug use, chemotherapy, uncontrolled depression etc.)
- Child is being adopted or will not be in the care of the mother
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback
This research is being done to find out if individualized feedback provided to parents on safe infant sleep can improve safety. This will be accomplished by having parents send photographs of their baby sleeping through the patient portal of the electronic health record (EHR).
Read the detailed description
The purpose of this study is to assess if photographs of infants sleeping at night sent by parents through the patient portal of the electronic health record (EHR) can be used to a) deliver individualized feedback on safe infant sleep surfaces and sleep health and b) improve parental knowledge of and adherence to guidelines for safe infant sleep surfaces and sleep health. The feasibility of this approach will also be assessed through a randomized, clinical trial involving 130 infants with primary care through Penn State Health. Participants will be randomized to receive personalized feedback on the infant sleep position and surface at age 1 month in addition to usual care or a usual care group. Both groups will receive personalized feedback on the infant sleep position and surface at infant age 2 months.
- Conditions
- SIDS, Infant Development
- Being tested
- Safe
- 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.
SafeBehavioural
Feedback, according to the 2016 national American Academy of Pediatrics (AAP) guidelines on Sudden Unexplained Infant Death (SUID) risk factors, will be generated by the study team and communicated with parents. Feedback will be given to parents in the intervention group at ages 1 and 2 months. The control group parents will only receive this feedback at age 2 months.
| Study group | Role | What they receive |
|---|---|---|
| intervention at 1 month + usual care | Active comparator | Parents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months. Receives: Behavioral: Safe |
| usual care | Placebo comparator | Parents will send the study team photographs of their infant sleeping during the night only at at age 2 months. Receives: Behavioral: Safe |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months
Safe sleep environment will include:
- Solitary vs. non-solitary sleep
- Supine vs. non-supine infant sleep position
- No loose objects vs. loose objects on the sleep surface
- Tight-bedding vs. loose-bedding
- Firm vs. soft sleep surface (i.e. crib/bassinete vs. sofa/bouncy chair)
- Infant's sleeping in same room as parents vs. separate room
- No head coverings vs. head coverings
Measured: 2 months of age
Secondary outcomes (1)
Parent compliance
Proportion of parents that send photographs of their infant's sleep environment at ages 1 month (intervention group) and 2 months (both groups)
Measured: 1 and 2 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start30 Oct 2018
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
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 SIDSStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian M. Paul, MD, Milton S. Hershey Medical Center
- Investigators
- Ian M Paul, MD, MSc, Principal investigator, Penn State Hershey Milton S Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662048
- Sponsor's protocol ID
- STUDY00010450
- Status last verified
- Oct 2019
- First submitted
- 5 Sep 2018
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to IPD with other researchers
Publications
TASK FORCE ON SUDDEN INFANT DEATH SYNDROME. SIDS and Other Sleep-Related Infant Deaths: Updated 2016 Recommendations for a Safe Infant Sleeping Environment. Pediatrics. 2016 Nov;138(5):e20162938. doi: 10.1542/peds.2016-2938. Epub 2016 Oct 24.
PubMed 27940804Canty EA, Fogel BN, Batra EK, Schaefer EW, Beiler JS, Paul IM. Improving infant sleep safety via electronic health record communication: a randomized controlled trial. BMC Pediatr. 2020 Oct 8;20(1):468. doi: 10.1186/s12887-020-02369-2.
PubMed 33032546
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback
- ClinicalTrials.gov ID
- NCT03662048
- Acronym / sponsor ID
- STUDY00010450
- Conditions
- SIDS, Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 7 Sep 2018 (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.
This research is being done to find out if individualized feedback provided to parents on safe infant sleep can improve safety. This will be accomplished by having parents send photographs of their baby sleeping through the patient portal of the electronic health record (EHR).
Detailed description
The purpose of this study is to assess if photographs of infants sleeping at night sent by parents through the patient portal of the electronic health record (EHR) can be used to a) deliver individualized feedback on safe infant sleep surfaces and sleep health and b) improve parental knowledge of and adherence to guidelines for safe infant sleep surfaces and sleep health. The feasibility of this approach will also be assessed through a randomized, clinical trial involving 130 infants with primary care through Penn State Health. Participants will be randomized to receive personalized feedback on the infant sleep position and surface at age 1 month in addition to usual care or a usual care group. Both groups will receive personalized feedback on the infant sleep position and surface at infant age 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention at 1 month + usual care | Active comparator | Behavioral: SafeParents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months. |
| usual care | Placebo comparator | Behavioral: SafeParents will send the study team photographs of their infant sleeping during the night only at at age 2 months. |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Gestational age: ≥37 weeks
- Singleton birth
- Newborns ages 0 days to 14 days old
- Newborn nursery stay <=7 days
- English speaking mother
Key exclusion criteria (2 listed)
- Maternal morbidity or pre-existing condition that affects ability to care for the newborn (e.g. narcotic drug use, chemotherapy, uncontrolled depression etc.)
- Child is being adopted or will not be in the care of the mother
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 |
|---|---|---|
| SafeFeedback, according to the 2016 national American Academy of Pediatrics (AAP) guidelines on Sudden Unexplained Infant Death (SUID) risk factors, will be generated by the study team and communicated with parents. Feedback will be given to parents in the intervention group at ages 1 and 2 months. The control group parents will only receive this feedback at age 2 months. | Behavioural | intervention at 1 month + usual care, usual care |
Primary outcome
percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months
Time frame: 2 months of age
Safe sleep environment will include: 1. Solitary vs. non-solitary sleep 2. Supine vs. non-supine infant sleep position 3. No loose objects vs. loose objects on the sleep surface 4. Tight-bedding vs. loose-bedding 5. Firm vs. soft sleep surface (i.e. crib/bassinete vs. sofa/bouncy chair) 6. Infant's sleeping in same room as parents vs. separate room 7. No head coverings vs. head coverings
1 secondary outcome
Parent compliance
Time frame: 1 and 2 months of age
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 11 Oct 2019.
- Background: PubMed 27940804TASK FORCE ON SUDDEN INFANT DEATH SYNDROME. SIDS and Other Sleep-Related Infant Deaths: Updated 2016 Recommendations for a Safe Infant Sleeping Environment. Pediatrics. 2016 Nov;138(5):e20162938. doi: 10.1542/peds.2016-2938. Epub 2016 Oct 24.
- Derived from this study: PubMed 33032546Canty EA, Fogel BN, Batra EK, Schaefer EW, Beiler JS, Paul IM. Improving infant sleep safety via electronic health record communication: a randomized controlled trial. BMC Pediatr. 2020 Oct 8;20(1):468. doi: 10.1186/s12887-020-02369-2.
- Individual participant dataSharing planned: No. no plan to IPD with other researchers
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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.
Ian M Paul, MD, MSc principal investigator
Penn State Hershey Milton S Hershey Medical Center
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 in people with SIDS and Infant Development, run by Milton S. Hershey Medical Center 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 10 inclusion and 2 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 11 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months (time frame: 2 months of age). 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 NCT03662048, 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 11 Oct 2019.