Improving Infant Sleep Safety With the Electronic Health Record

Related Clinical Trial
Social Media and Risk Reduction Teaching-Enhanced Reach The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands Improving Infant Sleep Safety With the Electronic Health Record Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder The Paediatric Virtual Autopsy Trial Impact of Smoke-free Legislation on Early-life Mortality and Low Birth Weight in England Generations in Families Talking Safe Sleep Enhancing Safe Sleep Practices of Urban Low-Income Mothers Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance Infant Care Practices Study Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program Magnetic Resonance Imaging Autopsy Study Do Pacifiers Protect From Sudden Infant Death Syndrome (SIDS) Through an Increase in Upper Airway Patency? Incidence and Severity of Cardiorespiratory Events in Infants at Increased Epidemiological Risk for Sudden Infant Death Syndrome (SIDS) Changes in Sleep Patterns and Stress in Infants Entering Child Care Parental Knowledge and Beliefs About Infant Sleep Position Influence of Pacifiers on Breastfeeding Duration Effect of Crystalloids With Different SID on pH, and Urinary Electrolytes During General Anesthesia Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)

Brief Title

Improving Infant Sleep Safety With the Electronic Health Record

Official Title

Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback

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).
    

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 Type

Interventional


Primary Outcome

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

Secondary Outcome

 Parent compliance

Condition

SIDS

Intervention

Safe

Study Arms / Comparison Groups

 intervention at 1 month + usual care
Description:  Parents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

130

Start Date

October 30, 2018

Completion Date

September 11, 2019

Primary Completion Date

September 11, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

N/A - 14 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ian M Paul, MD, MSc, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03662048

Organization ID

STUDY00010450


Responsible Party

Principal Investigator

Study Sponsor

Milton S. Hershey Medical Center


Study Sponsor

Ian M Paul, MD, MSc, Principal Investigator, Penn State Hershey Milton S Hershey Medical Center


Verification Date

October 2019