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

January 31, 2017 updated by: Centre For International Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Mulago Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 hour (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day
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.
2 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre For International Health

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 19, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMAvsFMV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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