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

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ClinicalTrials.gov Identifier: NCT02042118
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Makerere University
Information provided by (Responsible Party):
Centre For International Health

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE January 22, 2014
Last Update Posted Date February 1, 2017
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 19, 2014)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Randomized Clinical Trial Assessing Laryngeal Mask Airway Versus Face-mask Ventilation in Neonatal Resuscitation
Official Title  ICMJE Randomized Clinical Trial Assessing Laryngeal Mask Airway (LMA) Versus Face-mask Ventilation (FMV) in Neonatal Resuscitation at Mulago Hospital, Uganda
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asphyxia Neonatorum
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Laryngeal Mask Airway
    Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.
    Intervention: Device: Laryngeal Mask Airway
  • Active Comparator: Face mask ventilation
    Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes.
    Intervention: Device: Face mask ventilation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Hour   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02042118
Other Study ID Numbers  ICMJE LMAvsFMV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Centre For International Health
Study Sponsor  ICMJE Centre For International Health
Collaborators  ICMJE Makerere University
Investigators  ICMJE
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
PRS Account Centre For International Health
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP