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Completed

NCT Number: NCT03662048

Improving Infant Sleep Safety With the Electronic Health Record

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).

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Key information

Conditions

SIDS Death Death, Sudden Infant Death Infant Development Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Infant Death

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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:

    • 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

Secondary outcomes

  1. Parent compliance

    Time frame: 1 and 2 months of age

    Proportion of parents that send photographs of their infant's sleep environment at ages 1 month (intervention group) and 2 months (both groups)

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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