Supraglottic Airway for Resuscitation Trial

Study on Early Use of Breathing Devices During Newborn Resuscitation

E
Elizabeth Wetzel

Primary Investigator

Enrolling By Invitation
34 weeks - 1 year
All
Phase N/A
160 participants needed
1 Location

Brief description of study

The SUGAR Trial is a cluster-randomized, implementation trial evaluating two strategies to promote the use of early supraglottic airway (SA) rescue during neonatal resuscitation. No direct patient contact or intervention will occur, and all newborn data collection is covered under a waiver of consent and HIPAA authorization. 

THIS STUDY IS ENROLLING BY INVITATION ONLY - As a participating hospital in the DRIVE Network (IU IRB #21493), eligible newborns (≥34 weeks’ gestation who receive positive pressure ventilation at birth) will be identified using programmed logic within the DRIVE registry. The study team will collect de-identified clinical data from the DRIVE registry and medical records to confirm eligibility and abstract information on delivery room interventions, outcomes, and relevant covariates. 

Detailed description of study

The trial will be conducted in hospital inpatient units that care for newborns who require resuscitation at birth. Subject populations include (1) newborns who receive resuscitation at birth and (2) hospital staff who care for newborns who require resuscitation and participate in questionnaires and interviews. 

This is a cluster-randomized clinical trial with interventions assigned at the hospital level.  There are two categories of subjects:
• Hospital staff who are exposed to the interventions, complete study questionnaires,
and/or participate in qualitative interviews
o Maximum anticipated duration: Trial duration (4 years)


• Newborns who receive resuscitation who undergo data collection from the medical
record
o Maximum anticipated duration: length of hospital stay

IU investigators will also recruit and consent clinical providers and administrators involved in neonatal resuscitation to participate in two study components:

  1. Questionnaires (administered electronically via REDCap) assessing attitudes, perceptions, and practice norms related to SA use. Participation involves informed consent with a waiver of documentation.
  2. Qualitative interviews with a purposive sample of providers to explore experiences with implementation. Verbal informed consent will be obtained in accordance with IRB requirements.
  3. In addition to data collection, IU-affiliated investigators will support and implement site-specific activities associated with their randomized implementation strategy arm (either Enhanced or Enhanced-Plus), including provider education, simulation training, process evaluations, and monitoring.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Resuscitation at birth, Riley
  • Age: 34 weeks - 1 year
  • Gender: All

Patient Inclusion Criteria:
All liveborn infants at participating hospitals who meet the following criteria:
• Inborn (not transferred to the hospital after birth)
• ≥34 weeks’ gestation at birth, based on best obstetrical estimate, consistent with
current recommendations and guidelines for SA5,15
• Received PPV during neonatal resuscitation (as per provider’s clinical assessment).
Patient Exclusion criteria
• We will exclude patients born in hospital locations where the neonatal resuscitation
team is not responsible for resuscitation (i.e., trauma bay).
• There are no absolute contraindications to SA use for neonatal resuscitation for
patients ≥34 weeks’ gestation. However, two patient conditions where we will not
promote early SA rescue for the SUGAR trial are congenital diaphragmatic hernia
(CDH) and airway anomalies.
• Congenital diaphragmatic hernia. Consensus-based practice for CDH is to
immediately intubate after birth to initiate mechanical ventilation while avoiding
gastric distention. Therefore, CDH is a patient level exclusion for the trial. While
clinical providers may elect to use a supraglottic airway in a patient with CDH if
they are unable to intubate or for other clinical indications, we will exclude
patients with CDH from the trial population.
• Airway anomalies are broadly defined and include conditions such as Pierre-
Robin sequence, cleft lip/palate, tracheal-esophageal fistula, and
micro/retrognathia. SA devices are frequently used during airway management
for patients with airway anomalies, so SA use is expected and appropriate.
However, we excluded those patients from this trial because airway
management is often individualized, may involve subspecialists (ENT or
11
Anesthesia), and frequently requires additional equipment that is not available
during routine resuscitation

Clinical provider 1a inclusion criteria
• Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation
• Fluent in English

Administrator 1a inclusion criteria
• Oversee the care of newborns on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)
• Fluent in English


Clinical provider and administrator exclusion 1a criteria: No exclusion criteria


Clinical provider 1b inclusion criteria:
• Employed full-time by the hospital, affiliated practice, or affiliated university in amrole that involves newborn resuscitation
• Fluent in English
 

Clinical provider 1b exclusion criteria: No exclusion criteria

This study investigates the use of early supraglottic airway (SA) devices during neonatal resuscitation. Neonatal resuscitation is a medical procedure to help newborns start breathing at birth. The study collects data from newborns who need resuscitation and the hospital staff who provide it. It is conducted in hospitals that care for newborns needing resuscitation.

The study does not involve direct patient contact. Instead, it collects data from medical records and hospital staff through questionnaires and interviews. Hospital staff participating in the study will answer questions about their experiences and practices related to using SA devices. The study also includes educational activities for hospital staff.

  • Who can participate: Newborns born at participating hospitals who are at least 34 weeks' gestation and receive positive pressure ventilation at birth can participate. Hospital staff involved in neonatal resuscitation and administrators overseeing newborn care are also eligible.
  • Study details: Participants will not have any direct interventions. Hospital staff will complete questionnaires and interviews about their experiences with SA devices.
  • Study timelines: The study will last 4 years.
Updated on 23 Jul 2026. Study ID: PNEO-CHOP-SUGAR, 28317
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only