Improving Infant Sleep Safety With the Electronic Health Record

NCT03662048 | Completed

• 1 other identifier: STUDY00010450
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

SIDS; Infant Development

Outcome Measures

Primary Outcomes (1)

• percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months

  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

  2 months of age

Secondary Outcomes (1)

• Parent compliance

  1 and 2 months of age

Study Arms (2)

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.

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.

Behavioral: Safe

Interventions

Safe BEHAVIORAL

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.

intervention at 1 month + usual care; usual care

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

• 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.

  PMID: 27940804 BACKGROUND

• Canty 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.

  PMID: 33032546 DERIVED

MeSH Terms

Conditions

Sudden Infant Death

Interventions

Risk Evaluation and Mitigation

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Intervention Hierarchy (Ancestors)

Risk Management; Organization and Administration; Health Services Administration; Risk Assessment; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ian M Paul, MD, MSc

  Penn State Hershey Milton S Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 2 month photographs will be evaluated by study team members blinded to the study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Faculty Affairs, Department of Pediatrics

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: October 30, 2018
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)