Asphyxia NeonatorumLMAvsFMVNCT02042118
Randomized Clinical Trial Assessing Laryngeal Mask Airway Versus Face-mask Ventilation in Neonatal Resuscitation
A study testing Laryngeal Mask Airway and Face mask ventilation in people with Asphyxia Neonatorum, run by Centre For International Health at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages Up to 1 hour
- Conditions the study is for
- Asphyxia Neonatorum
- What is being tested?
- Laryngeal Mask Airway and Face mask ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 hour
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- estimated gestation > 34 weeks
- estimated weight > 2000 gram
- need for Positive Pressure Ventilation (PPV) at birth
Who cannot join
- still birth
- major malformations
- severe prenatal depression (Heart rate <60 1 minute after birth)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Assessing Laryngeal Mask Airway (LMA) Versus Face-mask Ventilation (FMV) in Neonatal Resuscitation at Mulago Hospital, Uganda
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.
Read the 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.
- Conditions
- Asphyxia Neonatorum
- Being tested
- Laryngeal Mask Airway, Face mask ventilation
- Keywords
- Neonatal resuscitation, Laryngeal Mask Airway (LMA), Face mask ventilation (FMV), Uganda, Africa
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask AirwayDevice
Also called I-gel size 1, Intersurgical Ltd, Wokingham, Berkshire,UK
Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.
Face mask ventilationDevice
Also called Face-mask ventilation, Neonatal resuscitator
Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Mask Airway | Experimental | Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes. Receives: Device: Laryngeal Mask Airway |
| Face mask ventilation | Active comparator | Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes. Receives: Device: Face mask ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one day
Secondary outcomes (2)
proportion of infants who require advanced resuscitation
To determine if use of LMA can reduce the proportion of infants who require advanced resuscitation
Measured: 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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Asphyxia NeonatorumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre For International Health
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University
- Responsible party
- Sponsor
- Investigators
- Thorkild Tylleskar, MD, PhD, Study chair, Centre for International Health, University of BergenNicolas J Pejovic, MD, Principal investigator, Centre for International Health, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042118
- Sponsor's protocol ID
- LMAvsFMV
- Acronym
- LMAvsFMV
- Status last verified
- Jan 2017
- First submitted
- 16 Dec 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22508912Ersdal 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.
PubMed 22198423Grein 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.
PubMed 15846656Zhu 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.
PubMed 21763393Carbine 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.
PubMed 11015505Nankabirwa 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.
PubMed 21573019Pejovic 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.
PubMed 27582031Pejovic 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.
PubMed 28912163
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Assessing Laryngeal Mask Airway (LMA) Versus Face-mask Ventilation (FMV) in Neonatal Resuscitation at Mulago Hospital, Uganda
- ClinicalTrials.gov ID
- NCT02042118
- Acronym / sponsor ID
- LMAvsFMV / LMAvsFMV
- Conditions
- Asphyxia Neonatorum
- Keywords
- Neonatal resuscitation, Laryngeal Mask Airway (LMA), Face mask ventilation (FMV), Uganda, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre For International HealthUniversity, hospital or other
- Collaborators
- Makerere University
- Study start
- Apr 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Mask Airway | Experimental | Device: Laryngeal Mask AirwayLaryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes. |
| Face mask ventilation | Active comparator | Device: Face mask ventilationFace-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes. |
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- estimated gestation > 34 weeks
- estimated weight > 2000 gram
- need for Positive Pressure Ventilation (PPV) at birth
Key exclusion criteria (3 listed)
- still birth
- major malformations
- severe prenatal depression (Heart rate <60 1 minute after birth)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal Mask AirwayAlso: I-gel size 1, Intersurgical Ltd, Wokingham, Berkshire,UKLaryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes. | Device | Laryngeal Mask Airway |
| Face mask ventilationAlso: Face-mask ventilation, Neonatal resuscitatorFace-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes. | Device | Face mask ventilation |
Primary outcome
time to spontaneous ventilation
Time frame: one day
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).
2 secondary outcomes
proportion of infants who require advanced resuscitation
Time frame: 1 day
the proportion of infants with adverse birth outcome
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Background: PubMed 22508912Ersdal 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.
- Background: PubMed 22198423Ersdal 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.
- Background: PubMed 15846656Grein 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.
- Background: PubMed 21763393Zhu 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.
- Background: PubMed 11015505Carbine 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.
- Background: PubMed 21573019Nankabirwa 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.
- Results publication: PubMed 27582031Pejovic 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.
- Derived from this study: PubMed 28912163Pejovic 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorkild Tylleskar, MD, PhD study chair
Centre for International Health, University of Bergen
Nicolas J Pejovic, MD principal investigator
Centre for International Health, University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Mask Airway and Face mask ventilation in people with Asphyxia Neonatorum, run by Centre For International Health at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to spontaneous ventilation (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02042118, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.