Randomized Clinical Trial Assessing Laryngeal Mask Airway Versus Face-mask Ventilation in Neonatal Resuscitation

Study Overview
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Brief Summary
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The purpose of this study is to compare the use of a laryngeal mask airway (LMA) vs. face-mask ventilation (FMV) during first-line neonatal resuscitation in Mulago Hospital, Kampala, Uganda.

Detailed Description
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Background: Perinatal mortality in Eastern Uganda 2007/2008 was estimated to 41/1000 pregnancies. The rate of stillbirth was 19/1000. In the whole of Uganda in 2008, neonatal deaths constituted 21% of an estimated 190,000 under five deaths, while HIV constituted only 5%. Implementing a Helping Babies Breathe (HBB) program in one centre in Tanzania resulted in almost 40 % reduction of early neonatal mortality. Introducing a neonatal intervention package even reduced the rate of stillbirths. Birth asphyxia (BA) accounted for 60% of early neonatal deaths in Haydom Lutheran Hospital, Tanzania. The need for resuscitation is greater in the neonate than in any other age group. Providing effective positive pressure ventilation (PPV) is the single most important component of successful neonatal resuscitation (5). Ventilation is frequently initiated with face-mask ventilation (FMV) followed by endotracheal intubation (ETT) if depression continues. These techniques may be difficult to perform resulting in prolonged resuscitation. The laryngeal mask airway (LMA) may achieve initial ventilation and successful resuscitation faster than a face-mask device or ETT. Various publications and a Cochrane review has shown LMA to be as efficient as ETT. Important air leakage during FMV is an issue. LMA reduces the need for ETT. The latest generation of LMA is made of a medical-grade gel-like elastomer designed to provide an efficient seal to the larynx without an inflatable cuff. The risk for trauma is minimised. Insertion is easy with a low risk of tissue compression or dislodgement. In a study to evaluate educational intervention in the Democratic Republic of Congo, both physicians and midwifes showed a good level of expertise in LMA insertion on mannequins. Both groups almost unanimously manifested a high degree of approval of neonatal resuscitation with LMA. Objective: To compare the use of uncuffed LMA vs. FMV during neonatal resuscitation in Mulago Hospital, Kampala, Uganda. Study design, setting and population: A randomized clinical trial will be conducted in Mulago hospital among asphyxiated neonates in the delivery unit. Approximately 33000 babies are born in this hospital each year. 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 LMA insertion. A total of 50 neonates will be randomized into being resuscitated with FMV or LMA. A trained midwife under supervision of a paediatrician/anaesthesiologist will initiate the resuscitation. Data from the intervention will be recorded by a research assistant and by video. Resuscitation lasting more than 150 seconds will be handed over to the supervising physician. Resuscitation will be performed according to international guidelines. Utility of study: Findings from this study will determine if uncuffed LMA can improve outcome of asphyxiated newborn in a large delivery ward where resuscitation is performed by midwifes. Data will also show us whether uncuffed LMA is superior to FMV after a training course according to the 2010 Guidelines on Neonatal Resuscitation (AHA, European Resuscitation Council [ERC], ILCOR). The Millennium Development Goals 4 (MDG-4) aims for the reduction of child mortality by two thirds from 1990 to 2015. It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.

Official Title
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Randomized Clinical Trial Assessing Laryngeal Mask Airway (LMA) Versus Face-mask Ventilation (FMV) in Neonatal Resuscitation at Mulago Hospital, Uganda

Conditions
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Asphyxia Neonatorum

Intervention / Treatment
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* Device: Laryngeal Mask Airway
* Device: Face mask ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: estimated gestation > 34 weeks estimated weight > 2000 gram need for Positive Pressure Ventilation (PPV) at birth Exclusion Criteria: still birth major malformations severe prenatal depression (Heart rate <60 1 minute after birth)

Ages Eligible for Study
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Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laryngeal Mask Airway<br>Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes. | Device: Laryngeal Mask Airway<br>* Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.<br>* Other names: I-gel size 1, Intersurgical Ltd, Wokingham, Berkshire,UK;|
| Active Comparator: Face mask ventilation<br>Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes. | Device: Face mask ventilation<br>* Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes.<br>* Other names: Neonatal resuscitator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to spontaneous ventilation | To assess if the ventilation time needed for neonates with an estimated birth weight of 2 kg or above and in need of initial respiratory support can be decreased from an average of 132 seconds in infants being resuscitated using FMV (control arm) to an average ventilation time of 72 seconds for infants resuscitated with the use of LMA (interventions arm). | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of infants who require advanced resuscitation | To determine if use of LMA can reduce the proportion of infants who require advanced resuscitation | 1 day | 
| the proportion of infants with adverse birth outcome | To assess the proportion of infants with adverse outcome (death or hospitalization) at 24 and 48 hours of life. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal resuscitation, Laryngeal Mask Airway (LMA), Face mask ventilation (FMV), Uganda, Africa