Clinical Trial: Neonatal Resuscitation With Supraglottic Airway Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Neonatal Supraglottic Airway Trial: A Multi-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early N

Brief 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 mortality at 7 days, morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.

STUDY DESIGN, SETTING AND POPULATION A multi-centre randomized clinical trial will be conducted at Central Hospital, Beira, Mozambique and at Mulago 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.

Detailed Summary:

One of the targets in the SDG-3 is to reduce neonatal mortality to less than 12 per 1000 live births by 2030. This will require considerable effort in many low-income countries. Perinatal mortality contributes to 40% of infant mortality in Uganda. Early neonatal death from birth asphyxia (BA) could be as high 60%. New evidence-based strategies are needed to reduce mortality from BA in order to achieve SDG-3 by 2030.

Optimal care of the depressed newborn is crucial to prevent and manage BA. The challenge in low-income settings is that highly qualified staff is not readily available to attend to the newborn who require their expertise. In most cases, the midwives are the most skilled personal attending to deliveries and also responsible for resuscitating newborns. At present in low-income settings, FMV is the commonly used method for resuscitating depressed newborn. Easy-to-use equipment such as a supraglottic airway could contribute to obtain more effective ventilation, and improve the outcome of the infant.

This trial is based on a previous pilot trial ClinicalTrials.gov Identifier: NCT02042118.

Primary objective

• To assess if the proportion of either early neonatal death or morbidity [admission to Neonatal Intensive Care Unit (NICU) with neonatal encephalopathy (maximum Thompson score 11 or above)], can be decreased from 40 % in the control arm (using FM) to 30 % in the intervention arm (using i-gel supraglottic airway), a 25% decrease.

Secondary objectives

• To assess if the proportion of early neonatal deaths is lower in the intervention arm compared to the control arm
• A composite outcome of a) 7-day mortality b) neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation).