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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02042118
First Posted: January 22, 2014
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Makerere University
Information provided by (Responsible Party):
Centre For International Health
  Purpose
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.

Condition Intervention
Asphyxia Neonatorum Device: Laryngeal Mask Airway Device: Face mask ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Assessing Laryngeal Mask Airway (LMA) Versus Face-mask Ventilation (FMV) in Neonatal Resuscitation at Mulago Hospital, Uganda

Resource links provided by NLM:


Further study details as provided by Centre For International Health:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • proportion of infants who require advanced resuscitation [ Time Frame: 1 day ]
    To determine if use of LMA can reduce the proportion of infants who require advanced resuscitation

  • the proportion of infants with adverse birth outcome [ Time Frame: 2 days ]
    To assess the proportion of infants with adverse outcome (death or hospitalization) at 24 and 48 hours of life.


Other Outcome Measures:
  • Proportion of times the midwife successfully inserts the LMA and deliver efficient PPV [ Time Frame: 1 day ]
    To determine if midwifes can learn to insert LMA and deliver efficient PPV.

  • Proportion of times the midwife successfully deliver efficient PPV using FMV [ Time Frame: 1 day ]
    To determine the best way for midwifes that have gone through the Helping Babies Breathe (HBB) curriculum to deliver PPV

  • proportion of video recordings that provides the necessary elements for QA [ Time Frame: 1 day ]
    To determine if video recording can be used for Quality assurance (QA) of resuscitation and data collection.


Enrollment: 50
Actual Study Start Date: April 2014
Study Completion Date: December 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laryngeal Mask Airway
Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.
Device: Laryngeal Mask Airway
Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.
Other Name: I-gel size 1, Intersurgical Ltd, Wokingham, Berkshire,UK
Active Comparator: Face mask ventilation
Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes.
Device: Face mask ventilation
Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes.
Other Names:
  • Face-mask ventilation
  • Neonatal resuscitator

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 1 Hour   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042118


Locations
Uganda
Mulago Teaching Hospital
Kampala, Uganda
Sponsors and Collaborators
Centre For International Health
Makerere University
Investigators
Study Chair: Thorkild Tylleskar, MD, PhD Centre for International Health, University of Bergen
Principal Investigator: Nicolas J Pejovic, MD Centre for International Health, University of Bergen
  More Information

Publications:

Responsible Party: Centre For International Health
ClinicalTrials.gov Identifier: NCT02042118     History of Changes
Other Study ID Numbers: LMAvsFMV
First Submitted: December 16, 2013
First Posted: January 22, 2014
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Centre For International Health:
Neonatal resuscitation
Laryngeal Mask Airway (LMA)
Face mask ventilation (FMV)
Uganda
Africa

Additional relevant MeSH terms:
Asphyxia
Asphyxia Neonatorum
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases