RECRUITING

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

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Conditions

Infant DeathSerious Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This postmarket surveillance study will evaluate the safety of the SNOO Smart Sleeper Bassinet when used for infants who are at high risk for Sudden Unexpected Infant Death (SUID). This study will survey 1000 caregivers of high-risk infants to examine the frequency of death or serious injury occurring in the SNOO Bassinet.

Official Title

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Quick Facts

Study Start:2023-11-29
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06361303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Respondent must identify as a primary caregiver of the infant.
  2. * Purchase or rental of SNOO shipped to a U.S. residence during the defined enrollment period.
  3. * Caregivers must be English speakers ages 18 or older residing in the United States.
  4. * Infants must use SNOO during the intended use period (i.e., birth to 6 months).
  5. * Infants must meet at least one of the following criteria for high risk for SUID:
  6. * Infant race: Black or African American; and/or American Indian or Alaskan Native
  7. * Maternal education: 12 years or less
  8. * Low birth weight: \<5 pounds 8 ounces (\<2500 grams)
  9. * Last menstrual cycle (LMP) or obstetrical estimate (OE) Gestational age at time of birth: \<37 weeks (preterm)
  10. * Maternal age at time of birth: \<25 years
  11. * Smoking status: Any self-reported maternal smoking during pregnancy
  1. * Not primary caregiver
  2. * Does not speak English
  3. * Is not a US resident
  4. * Is not 18 years old or older
  5. * Infant did not use SNOO during the intended use period (i.e., birth to 6 months).
  6. * Infants does NOT meet at least one of the below risk criteria:
  7. * Infant race: Black or African American; and/or American Indian or Alaskan Native
  8. * Maternal education: 12 years or less
  9. * Low birth weight: \<5 pounds 8 ounces (\<2500 grams)
  10. * LMP or OE Gestational age at time of birth: \<37 weeks (preterm)
  11. * Maternal age at time of birth: \<25 years
  12. * Smoking status: Any self-reported maternal smoking during pregnancy

Contacts and Locations

Study Contact

Christopher Laine, PhD
CONTACT
310-476-9358
christopher@happiestbaby.com
Sarah Chang, MPH
CONTACT
310-476-9358
schang@happiestbaby.com

Principal Investigator

Christopher Laine, PhD
PRINCIPAL_INVESTIGATOR
Happiest Baby, Inc.

Study Locations (Sites)

Happiest Baby, Inc.
Los Angeles, California, 90064
United States

Collaborators and Investigators

Sponsor: Happiest Baby, Inc.

  • Christopher Laine, PhD, PRINCIPAL_INVESTIGATOR, Happiest Baby, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-29
Study Completion Date2025-09

Study Record Updates

Study Start Date2023-11-29
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Infant Death
  • Serious Injury