Asphyxia Neonatorum Clinical Trial
Official title:
Neonatal Supraglottic Airway Trial: A Single-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity
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.
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 neonatal encephalopathy
(admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation),
can be decreased from 40 % in the control arm (using FM) to 30 % or less in the intervention
arm (using i-gel supraglottic airway), a 25% decrease.
Secondary objectives
- To assess the safety of a supraglottic airway in the hands of lower cadre (non-doctor)
birth attendants in Africa.
- To assess if the proportion of very early and early neonatal deaths is lower in the
intervention arm compared to the control arm.
- To assess if the proportion of neonatal encephalopathy (admission to NICU with maximum
Thompson score 11 or above), is lower in the intervention arm compared to the control
arm.
- To assess if the proportion of neonatal encephalopathy (admission to Neonatal Intensive
Care Unit - NICU - with maximum Thompson score 7 or above), is lower in the intervention
arm compared to the control arm.
- To assess if hospital admission rate in the first 7 days of life is lower in the
intervention arm compared to the control arm.
- To assess the need of advanced resuscitation in the intervention arm compared to the
control arm.
Study justification and significance
Training midwives and other birth-attendants can save lives. However, delivering effective
positive pressure ventilation (PPV) with FM is a delicate task that requires continuous
(re)training. In a previous phase II trial (NCT02042118), it has been shown that a
supraglottic airway is safe to use, even in the hands of midwives and with the potential to
deliver efficient PPV and perhaps even improve outcome of asphyxiated babies. The cuffless
i-gel is simple to use and could therefore be the ideal device to resuscitate newborn when
experienced physicians are not available.
Prior to interventions: training midwives in neonatal resuscitation skills
Helping Babies Breathe (HBB) is an evidence-based educational program to teach neonatal
resuscitation techniques in resource-limited areas. It is an initiative of the American
Academy of Pediatrics (AAP) in collaboration with the World Health Organization (WHO), US
Agency for International Development (USAID), Saving Newborn Lives, the National Institute of
Child Health and Development, and a number of other global health organizations.
The objective of HBB is to train birth attendants in developing countries in the essential
skills of newborn resuscitation, with the goal of having at least one person who is skilled
in neonatal resuscitation at the birth of every baby.
The second edition of HBB is now available and will be used in the training.
Study procedures
It is estimated that around 5-10 % of babies born will need ventilation as part of the
resuscitation. This randomized trial will include all babies eligible for resuscitation. All
newborns in need of resuscitation will be randomized to receive initial treatment using
either:
- Supraglottic airway (intervention arm) or
- Face mask (active comparator arm).
The midwife will immediately move the babies not responding to stimulation to the
resuscitation area. Ventilation with supraglottic airway or face mask will be initiated
immediately. Apgar score and admission to the neonatal ward will be recorded by a research
assistant. The intervention may be recorded on video to ensure quality assurance and data
collection.
If the infant is hospitalised, daily assessment of Thompson score will be made by a skilled
paediatrician/physician. A follow-up visit on day 7 (or later) will determine the outcome (if
the infant is alive or not) together with the assessments of Thompson score.
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