Condition category
Pregnancy and Childbirth
Date applied
16/01/2008
Date assigned
21/01/2008
Last edited
21/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mike English

ORCID ID

Contact details

P.O. Box 43640
00100 GPO
Nairobi
-
Kenya
+254 (0)20 271 0672/272 0163
menglish@nairobi.kemri-wellcome.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SSC Protocol No. 1045 (Revised)

Study information

Scientific title

An operational evaluation of introducing training in newborn resuscitation for maternity ward staff at Pumwani hospital

Acronym

Study hypothesis

The primary research question is to examine the ability of training to change health workers' practices when providing newborn resuscitation.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Birth asphyxia

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Frequency of inappropriate and potentially harmful practices (e.g., inappropriate positioning, wrong oxygen use, etc.).

Overall trial start date

01/01/2006

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Intervention: 32; control: 58 (total : 90)

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2006

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Kenya

Trial participating centre

P.O. Box 43640
Nairobi
-
Kenya

Sponsor information

Organisation

Laerdal Foundation of Acute Medicine (Norway)

Sponsor details

P.O. Box 556 Sentrum
Stavanger
4003
Norway
post@laedalfoundation.org

Sponsor type

Research organisation

Website

http://www.laerdal.com

Funders

Funder type

Research organisation

Funder name

Laerdal Foundation of Acute Medicine (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) - Senior Research Fellowship award to Dr English (ref: 076827)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18270586

Publication citations

  1. Results

    Opiyo N, Were F, Govedi F, Fegan G, Wasunna A, English M, Effect of newborn resuscitation training on health worker practices in Pumwani Hospital, Kenya., PLoS ONE, 2008, 3, 2, e1599, doi: 10.1371/journal.pone.0001599.

Additional files

Editorial Notes