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

Asphyxia Neonatorum Clinical Trial

— LMAvsFMV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042118
• Other study ID #: LMAvsFMV
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: January 31, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Centre For International Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

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)

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum

Intervention

Device:
• Laryngeal Mask Airway
Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.
• Face mask ventilation
Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes.

Locations

Country	Name	City	State
Uganda	Mulago Teaching Hospital	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Centre For International Health	Makerere University

Country where clinical trial is conducted

Uganda, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Review. — View Citation

Nankabirwa V, Tumwine JK, Tylleskär 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. — View Citation

Pejovic NJ, Trevisanuto D, Nankunda J, Tylleskär 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of times the midwife successfully inserts the LMA and deliver efficient PPV	To determine if midwifes can learn to insert LMA and deliver efficient PPV.	1 day
Other	Proportion of times the midwife successfully deliver efficient PPV using FMV	To determine the best way for midwifes that have gone through the Helping Babies Breathe (HBB) curriculum to deliver PPV	1 day
Other	proportion of video recordings that provides the necessary elements for QA	To determine if video recording can be used for Quality assurance (QA) of resuscitation and data collection.	1 day
Primary	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	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
Secondary	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