NCT02042118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

December 16, 2013

Last Update Submit

January 31, 2017

Conditions

Asphyxia Neonatorum

Keywords

Neonatal resuscitationLaryngeal Mask Airway (LMA)Face mask ventilation (FMV)UgandaAfrica

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • proportion of infants who require advanced resuscitation

    1 day

  • the proportion of infants with adverse birth outcome

    2 days

Other Outcomes (3)

  • Proportion of times the midwife successfully inserts the LMA and deliver efficient PPV

    1 day

  • Proportion of times the midwife successfully deliver efficient PPV using FMV

    1 day

  • proportion of video recordings that provides the necessary elements for QA

    1 day

Study Arms (2)

Laryngeal Mask Airway

EXPERIMENTAL

Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.

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.

Device: Face mask ventilation

Interventions

Laryngeal Mask AirwayDEVICE

Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.

Also known as: I-gel size 1, Intersurgical Ltd, Wokingham, Berkshire,UK
Laryngeal Mask Airway
Face mask ventilationDEVICE

Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes.

Also known as: Face-mask ventilation, Neonatal resuscitator
Face mask ventilation

Eligibility Criteria

AgeUp to 1 Hour
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • estimated gestation \> 34 weeks
  • estimated weight \> 2000 gram
  • need for Positive Pressure Ventilation (PPV) at birth

You may not qualify if:

  • still birth
  • major malformations
  • severe prenatal depression (Heart rate \<60 1 minute after birth)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Teaching Hospital

Kampala, Uganda

Location

Related Publications (8)

  • 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.

    PMID: 22508912BACKGROUND

  • 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. Epub 2011 Dec 23.

    PMID: 22198423BACKGROUND

  • 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. doi: 10.1002/14651858.CD003314.pub2.

    PMID: 15846656BACKGROUND

  • 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. Epub 2011 Jul 16.

    PMID: 21763393BACKGROUND

  • 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. doi: 10.1542/peds.106.4.654.

    PMID: 11015505BACKGROUND

  • Nankabirwa 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.

    PMID: 21573019BACKGROUND

  • Pejovic 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.

    PMID: 27582031RESULT

  • Pejovic 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.

    PMID: 28912163DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Thorkild Tylleskar, MD, PhD

    Centre for International Health, University of Bergen

    STUDY CHAIR

  • Nicolas J Pejovic, MD

    Centre for International Health, University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

January 22, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

December 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

UG(1)