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Behavioral: Standard of Care Control for Sudden Infant Death Syndrome (GIFTSS Trial)

N/A
Waitlist Available
Led By Mary E Aitken, MD, MPH
Research Sponsored by Arkansas Children's Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 months post delivery
Awards & highlights

GIFTSS Trial Summary

Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position and they make seek advice from older female support people. Investigators will conduct a randomized controlled trial of a educational intervention to mitigate the risks of unsafe infant sleep practices across generations. Given the complexity and variability of teen-SCG relationships, investigators will include an examination of inter- and intra-personal factors that are key control variables or may mediate the uptake of safe sleep recommendations. Investigators believe that the intervention will empower support people to positively influence a teen mother's adoption of safe sleep recommendations.

Eligible Conditions
  • Sudden Infant Death Syndrome

GIFTSS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 months post delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 months post delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Use of safe sleep environment

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

GIFTSS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral: Standard of Care ControlExperimental Treatment1 Intervention
Standard of care.
Group II: Behavioral: Safety Baby shower Teen OnlyActive Control1 Intervention
Only the teen will receive the educational intervention.
Group III: Behavioral: Safety Baby shower DyadActive Control1 Intervention
Both the teen and the teens support person will receive the educational intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420

Find a Location

Who is running the clinical trial?

Arkansas Children's Hospital Research InstituteLead Sponsor
135 Previous Clinical Trials
5,029,219 Total Patients Enrolled
Mary E Aitken, MD, MPHPrincipal InvestigatorArkansas Children's Hospital Research Institute

Frequently Asked Questions

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~14 spots leftby Apr 2025