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Newborn resuscitation study in Pumwani, Kenya
ISRCTN ISRCTN92218092
DOI 10.1186/ISRCTN92218092
ClinicalTrials.gov identifier
EudraCT number
Public title Newborn resuscitation study in Pumwani, Kenya
Scientific title An operational evaluation of introducing training in newborn resuscitation for maternity ward staff at Pumwani hospital
Acronym N/A
Serial number at source SSC Protocol No. 1045 (Revised)
Study hypothesis The primary research question is to examine the ability of training to change health workers' practices when providing newborn resuscitation.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Kenya Medical Research Institute National Ethical Review Committee on the 24th January 2006 (ref. SSC Protocol No 1045 [Revised]).
Study design Cluster-randomised trial with health workers as the unit of randomisation
Countries of recruitment Kenya
Disease/condition/study domain Birth asphyxia
Participants - inclusion criteria All nurses/midwives (age range: 27 - 51), either sex, expected to provide delivery care and newborn resuscitation for a period of at least 3 months after the start of the trial.
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/01/2006
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material
Target number of participants Intervention: 32; control: 58 (total : 90)
Interventions We intend to collect data on up to 5 resuscitation episodes for 28 health workers in the training group and more in the control group that should ensure our ability to detect a 25% absolute change in our primary outcome measure.

A list of the eligible staff will be made and 40% will be randomly selected and will comprise the early training group (i.e. intervention group). The remainder will comprise the control or late training group and will be trained after completion of data collection in the intervention group. For both intervention and control arms, we estimate that at best 3 to 5 observations could be made per health worker over a 6 to 7 weeks period.

The intervention is newborn life support (NLS) training supervised by trainers who have completed the European Resuscitation Council's Advanced Life Support Generic Instructor Course. The training will last 7 working hours and will be delivered on-site. This training comprises focused lectures aimed at understanding the modern approach to resuscitation and practical training using infant manikins to develop skills in airway opening, use of bag-valve-mask to inflate the chest and chest (cardiac) compressions. The course teaches an A (Airway), B (Breathing), C (Circulation) approach to resuscitation laying down a clear, step by step strategy for the first minutes of resuscitation for all resuscitation episodes conducted by nurse/midwives.
Primary outcome measure(s) Proportion of resuscitation episodes in which appropriate initial resuscitation steps were practised as recommended in the NLS training (i.e., to open airway and assess breathing).
Secondary outcome measure(s) Frequency of inappropriate and potentially harmful practices (e.g., inappropriate positioning, wrong oxygen use, etc.).
Sources of funding 1. Laerdal Foundation of Acute Medicine (Norway)
2. The Wellcome Trust (UK) - Senior Research Fellowship award to Dr English (ref: 076827)
Trial website
Publications 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18270586
Contact name Dr  Mike  English
  Address P.O. Box 43640
00100 GPO
  City/town Nairobi
  Zip/Postcode -
  Country Kenya
  Tel +254 (0)20 271 0672/272 0163
  Fax +254 (0)20 271 1673
  Email menglish@nairobi.kemri-wellcome.org
Sponsor Laerdal Foundation of Acute Medicine (Norway)
  Address P.O. Box 556 Sentrum
  City/town Stavanger
  Zip/Postcode 4003
  Country Norway
  Email post@laedalfoundation.org
  Sponsor website: http://www.laerdal.com
Date applied 16/01/2008
Last edited 21/03/2013
Date ISRCTN assigned 21/01/2008
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