Neonatal Resuscitation With Supraglottic Airway Trial

Summary

Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can be trained in a short time to use this method. A pilot study in Uganda has demonstrated that midwives can safely perform resuscitation of newborn with the i-gel.

OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7 days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.

STUDY DESIGN, SETTING AND POPULATION A single-centre randomized clinical trial will be conducted at Mulago National Referral Hospital, Kampala, Uganda, among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the labour ward performing resuscitation will receive training according to the HBB curriculum with a special module for training on supraglottic airway insertion. Resuscitation will be performed according to international guidelines.

UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.

Conditions

• Asphyxia Neonatorum

Interventions

DEVICE

Supraglottic airway

Instead of using a conventional face mask to provide positive pressure ventilation during neonatal resuscitation we are using a supraglottic airway and a conventional bag.

DEVICE

Face-mask

In order to provide positive pressure ventilation during neonatal resuscitation we are using a conventional face-mask and a conventional bag.

Sponsors & Collaborators

• Makerere University

  collaborator OTHER

• University of Padova

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Doctors with Africa - CUAMM

  collaborator OTHER

• Centre For International Health

  lead OTHER

Principal Investigators

• Thorkild Tylleskär, MD, PhD · University of Bergen, Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

10 Minutes

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-08

Primary Completion

2019-08-12

Completion

2021-12-31

Countries

• Uganda

Study Locations