Newborn resuscitation study in Pumwani, Kenya

ISRCTN	ISRCTN92218092
DOI	https://doi.org/10.1186/ISRCTN92218092
Protocol serial number	SSC Protocol No. 1045 (Revised)
Sponsor	Laerdal Foundation of Acute Medicine (Norway)
Funders	Laerdal Foundation of Acute Medicine (Norway), The Wellcome Trust (UK) - Senior Research Fellowship award to Dr English (ref: 076827)

Submission date: 16/01/2008
Registration date: 21/01/2008
Last edited: 21/03/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mike English
Scientific

P.O. Box 43640
00100 GPO
Nairobi
-
Kenya

Phone	+254 (0)20 271 0672/272 0163
Email	menglish@nairobi.kemri-wellcome.org

Study information

Primary study design	Interventional
Study design	Cluster-randomised trial with health workers as the unit of randomisation
Secondary study design	Randomised controlled trial
Scientific title	An operational evaluation of introducing training in newborn resuscitation for maternity ward staff at Pumwani hospital
Study objectives	The primary research question is to examine the ability of training to change health workers' practices when providing newborn resuscitation.
Ethics approval(s)	Ethics approval received from the Kenya Medical Research Institute National Ethical Review Committee on the 24th January 2006 (ref. SSC Protocol No 1045 [Revised]).
Health condition(s) or problem(s) studied	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
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).
Key secondary outcome measure(s)	Frequency of inappropriate and potentially harmful practices (e.g., inappropriate positioning, wrong oxygen use, etc.).
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	90
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Kenya

Study participating centre

P.O. Box 43640

Nairobi
-
Kenya

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/02/2008		Yes	No