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Trial record 4 of 22 for:    Ian Paul

Improving Infant Sleep Safety With the Electronic Health Record

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662048
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ian M. Paul, MD, Milton S. Hershey Medical Center

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).

Condition or disease Intervention/treatment Phase
SIDS Infant Development Behavioral: Safe Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: 2 month photographs will be evaluated by study team members blinded to the study group.
Primary Purpose: Prevention
Official Title: Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : September 11, 2019
Actual Study Completion Date : September 11, 2019

Arm Intervention/treatment
Active Comparator: intervention at 1 month + usual care
Parents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months.
Behavioral: Safe
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.

Placebo Comparator: usual care
Parents will send the study team photographs of their infant sleeping during the night only at at age 2 months.
Behavioral: Safe
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 Outcome Measures :
  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:

    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


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662048


Locations
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United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Ian M Paul, MD, MSc Penn State Hershey Milton S Hershey Medical Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ian M. Paul, MD, Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Faculty Affairs, Department of Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03662048    
Other Study ID Numbers: STUDY00010450
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No