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Vaginal Birth for Sudden Infant Death Syndrome (AWARD Trial)

N/A

Waitlist Available

Led By Guilherme Sant'Anna, MD, PhD

Research Sponsored by Guilherme Sant'Anna, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Newborns ≥35 weeks (gestational age)

2. Newborns determined to be clinically stable at delivery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to: 1. Assess feasibility 2. Evaluate safety 3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.

Eligible Conditions

Sudden Infant Death Syndrome
Infantile apnea

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the accuracy of this wireless system - bias.

Assess the accuracy of this wireless system - correlation coefficient.

Assess the accuracy of this wireless system - slope

+11 more

Secondary study objectives

Time between sensors placement and data display (seconds)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Vaginal BirthExperimental Treatment2 Interventions

Wireless monitoring system placed first for vaginal birth. 15-20 minutes later, the wired monitoring system is placed. Both systems stay in place for 2 hours.

Group II: C-Section BirthExperimental Treatment2 Interventions

System placement randomized for C-section. One system placed first and the alternate placed immediately after. Both systems stay in place for 2 hours.

0 / 3Eligibility criteria met