Clinical trial NCT02042118: Randomized Clinical Trial Assessing Laryngeal Mask Airway Versus Face-mask Ventilation in Neonatal Resuscitation
Official title: Randomized Clinical Trial Assessing Laryngeal Mask Airway (LMA) Versus Face-mask Ventilation (FMV) in Neonatal Resuscitation at Mulago Hospital, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asphyxia Neonatorum
Keywords: Neonatal resuscitation
Laryngeal Mask Airway (LMA)
Face mask ventilation (FMV)
Uganda
Africa
Lead sponsor: Centre For International Health
Sponsor class: OTHER
Collaborators: name: Makerere University
First posted: 2014-01-22
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: time to spontaneous ventilation
timeFrame: one day
Secondary outcomes:
measure: proportion of infants who require advanced resuscitation
timeFrame: 1 day
measure: the proportion of infants with adverse birth outcome
timeFrame: 2 days
Other outcomes:
measure: Proportion of times the midwife successfully inserts the LMA and deliver efficient PPV
timeFrame: 1 day
measure: Proportion of times the midwife successfully deliver efficient PPV using FMV
timeFrame: 1 day
measure: proportion of video recordings that provides the necessary elements for QA
timeFrame: 1 day
Locations:
city: Kampala
country: Uganda
facility: Mulago Teaching Hospital
Study officials:
affiliation: Centre for International Health, University of Bergen
name: Thorkild Tylleskar, MD, PhD
role: STUDY_CHAIR
affiliation: Centre for International Health, University of Bergen
name: Nicolas J Pejovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ersdal HL, Mduma E, Svensen E, Perlman J. Birth asphyxia: a major cause of early neonatal mortality in a Tanzanian rural hospital. Pediatrics. 2012 May;129(5):e1238-43. doi: 10.1542/peds.2011-3134. Epub 2012 Apr 16.
citation: Ersdal HL, Mduma E, Svensen E, Perlman JM. Early initiation of basic resuscitation interventions including face mask ventilation may reduce birth asphyxia related mortality in low-income countries: a prospective descriptive observational study. Resuscitation. 2012 Jul;83(7):869-73. doi: 10.1016/j.resuscitation.2011.12.011. Epub 2011 Dec 23.
citation: Grein AJ, Weiner GM. Laryngeal mask airway versus bag-mask ventilation or endotracheal intubation for neonatal resuscitation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003314. doi: 10.1002/14651858.CD003314.pub2.
citation: Zhu XY, Lin BC, Zhang QS, Ye HM, Yu RJ. A prospective evaluation of the efficacy of the laryngeal mask airway during neonatal resuscitation. Resuscitation. 2011 Nov;82(11):1405-9. doi: 10.1016/j.resuscitation.2011.06.010. Epub 2011 Jul 16.
citation: Carbine DN, Finer NN, Knodel E, Rich W. Video recording as a means of evaluating neonatal resuscitation performance. Pediatrics. 2000 Oct;106(4):654-8. doi: 10.1542/peds.106.4.654.
citation: Nankabirwa V, Tumwine JK, Tylleskar T, Nankunda J, Sommerfelt H; PROMISE EBF Research Consortium. Perinatal mortality in eastern Uganda: a community based prospective cohort study. PLoS One. 2011 May 9;6(5):e19674. doi: 10.1371/journal.pone.0019674.
citation: Pejovic NJ, Trevisanuto D, Nankunda J, Tylleskar T. Pilot manikin study showed that a supraglottic airway device improved simulated neonatal ventilation in a low-resource setting. Acta Paediatr. 2016 Dec;105(12):1440-1443. doi: 10.1111/apa.13565.
citation: Pejovic NJ, Trevisanuto D, Lubulwa C, Myrnerts Hook S, Cavallin F, Byamugisha J, Nankunda J, Tylleskar T. Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda. Arch Dis Child. 2018 Mar;103(3):255-260. doi: 10.1136/archdischild-2017-312934. Epub 2017 Sep 14.