The SUGAR Trial is the first clinical trial embedded within the Delivery Room Intervention and Evaluation (DRIVE) Network. The DRIVE Network is a US-based collaborative that collects and studies delivery room resuscitation data to identify best practices and improve provider performance, training and outcomes for newborns requiring resuscitation at birth. For more information about DRIVE, follow this link.

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Importance of the topic:

Among 3.8 million babies born in the US every year, 10% require resuscitation to breathe immediately after birth. Positive pressure ventilation (PPV) is the most important intervention during neonatal resuscitation and is most frequently delivered through a facemask. In many cases, facemask PPV does not work immediately due to challenges such as facemask leak and airway obstruction. This delays effective ventilation, prevents oxygen delivery to the baby, and can cause organ damage. Historically, placing a breathing tube through a process called intubation is needed when facemask PPV fails. However, intubation is a risky and technically challenging procedure, and not all neonatal providers are trained to perform intubation. 

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A supraglottic airway is a safe, easy to use, FDA-approved alternative airway to provide PPV for babies who are born at or near term. Many randomized trials have demonstrated that the supraglottic airway is better than the facemask to provide effective PPV, and the supraglottic airway does not require special training to place. Although US neonatal resuscitation guidelines recommend supraglottic airways, they are rarely used by clinicians who perform neonatal resuscitation.  

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The SUGAR Trial:

The SUGAR (Supraglottic Airway for Resuscitation) trial was designed to address this evidence to practice gap and learn how best to implement supraglottic airway use for newborns who are at least 34 weeks’ gestation when they are born and who receive PPV during neonatal resuscitation.  

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SUGAR (Supraglottic Airway for Resuscitation) trial will compare two implementation strategies in participating hospitals:

• The Enhanced Standard of Care (“Enhanced”) strategy includes a package of five implementation tools to promote supraglottic airway use that hospitals can use without external support.  

• Enhanced Standard of Care Plus Facilitation (“Enhanced Plus”) strategy includes all five tools in the Enhanced strategy plus two tools that use external facilitation. External facilitation means hospitals will receive extra support from outside experts and peer hospitals who have successfully implemented the supraglottic airway.

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The SUGAR Trial will: 

• Compare the two types of implementation strategies to see which type works best for increasing clinicians’ use of the supraglottic airway during neonatal resuscitation.

• Determine if increasing supraglottic airway use in participating hospitals is associated with improved patient-centered outcomes for newborns who receive resuscitation.

• Evaluate how and why each approach worked.

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Who partners with the research team and who this research will help:

• Multiple partners are involved with this study, including parents whose newborns required resuscitation, clinicians, administrators, researchers, and national organizations who develop neonatal resuscitation guidelines.

• Resuscitation organizations, hospitals, and clinicians can use findings from this study to understand which approaches work best to increase use of the supraglottic airway during neonatal resuscitation.

• Study results may also help these groups more broadly understand how to implement new neonatal resuscitation guidelines and practices in the future.

• Together, these new learnings will help to improve the care for newborns who require resuscitation after birth.

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