Plain English Summary
Background and study aims
Neonatal asphyxia is a medical condition that happens when a baby's brain and other organs do not get enough oxygen before, during or right after birth. This leads to almost a million deaths every year, which almost exclusively happen in low or middle income countries. For babies who are suffering from this lack of oxygen (hypoxia), a delay in receiving emergency care, such as resuscitation, can lead to severe disability in the child. This is a particular problem in these countries as a large number of births take place outside health facilities or without a skilled birth attendant present. In order to try to prevent disability and death, the American Academy of Paediatrics has developed an educational programme called “Helping Babies Breathe” (HBB). This training package is designed to train birth attendants in developing countries in essential skills of how to effectively treat hypoxia. The aim of this study is to find out whether an introduction of a simplified Neonatal Resuscitation Protocol (HBB) will improve the survival rate and overall outcome for babies suffering from hypoxia.
Who can participate?
Newborns delivered at Paropakar Maternity and Women's Hospital during the study period.
What does the study involve?
Birth attendants are provided with training in a simplified Neonatal Resuscitation Protocol (HBB), which is then used in the hospital. The number of neonatal deaths is counted over a six-month period when birth attendants are actively trained in the HBB practices. The results are then compared with a period of six months before the training began, and a period of three months after the active training ends.
What are the possible benefits and risks of participating?
A potential benefit of participating in the study is improved care offered by the trained health professionals. There are no potential risks of participating in the study.
Where is the study run from?
Paropakar Maternity and Women's Hospital (Nepal)
When is the study starting and how long is it expected to run for?
July 2012 to September 2013
Who is funding the study?
1. Laerdal Foundation (Norway)
2. Uppsala University (Sweden)
Who is the main contact?
Dr Ashish Kc
ashish.k.c@kbh.uu.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ashish KC
ORCID ID
Contact details
Population Service International
Shree Mahalaxmi Sadan
GPO Box 21976
Mahalaxmisthan
Lagankhel
Lalitpur
-
Nepal
-
ashish.k.c@kbh.uu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluating the implementation of a simplified Neonatal Resuscitation Protocol - Helping Baby Breathe at Birth (HBB) - in a tertiary level hospital in Nepal on perinatal outcome and survival using a before-after study design
Acronym
Study hypothesis
The introduction of a simplified Neonatal Resuscitation Protocol (HBB) will significantly improve perinatal outcome and survival in the study setting.
Ethics approval
1. Institutional Research Committee - Ministry of Health and Population in Nepal, ref: 2068-11-02BS
2. Ethical Review Board of Uppsala University, 15/08/2012, ref: 2012/267
Study design
Prospective cohort study with before and after design
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Perinatal mortality
Intervention
After a six month baseline period a simplified algorithm for neonatal resuscitation at birth - Helping Babies Breathe (HBB) will be implemented in the hospital. In order to improve the adherence of the birth attendants towards this new guideline on neonatal resuscitation a framework of quality improvement cycle will be instituted.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Perinatal mortality
Secondary outcome measures
1. Apgar score at 1, 5 and 10 minutes
2. Saturation at 5 and 10 minutes
3. Length of hospital stay
4. Performance of heatlh staff at resuscitation (time to initiation, time of effective ventiolation etc.)
5. Knowledge level and in-training performance of health staff
Overall trial start date
01/07/2012
Overall trial end date
30/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All newborns delivered at Paropakar Maternity and Women's Hospital in Kathmandu, Nepal during study period
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
28000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/07/2012
Recruitment end date
30/09/2013
Locations
Countries of recruitment
Nepal
Trial participating centre
Population Service International
Lalitpur
-
Nepal
Sponsor information
Organisation
Uppsala University (Sweden)
Sponsor details
Department of Women's and Children's Health
University Hospital
Uppsala
75185
Sweden
+46 (0)18 471 00 00
mats.malqvist@kbh.uu.se
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Laerdal Foundation (Norway)
Alternative name(s)
Laerdal Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Norway
Funder name
Uppsala Universitet
Alternative name(s)
Uppsala University
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Sweden
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
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23039709
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26143456
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26359230
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26359230
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27581467
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29386046
Publication citations
-
Protocol
Ashish KC, Målqvist M, Wrammert J, Verma S, Aryal DR, Clark R, Naresh PK, Vitrakoti R, Baral K, Ewald U, Implementing a simplified neonatal resuscitation protocol-helping babies breathe at birth (HBB) - at a tertiary level hospital in Nepal for an increased perinatal survival., BMC Pediatr, 2012, 12, 159, doi: 10.1186/1471-2431-12-159.
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Results
Kc A, Nelin V, Wrammert J, Ewald U, Vitrakoti R, Baral GN, Målqvist M, Risk factors for antepartum stillbirth: a case-control study in Nepal, BMC Pregnancy Childbirth, 2015, 15, 1, 146.
-
Results
Ashish KC, Johan Wrammert, Viktoria Nelin, Uwe Ewald, Robert Clark and Mats Målqvist, Level of mortality risk for babies born preterm or with a small weight for gestation in a tertiary hospital of Nepal, BMC Public Health, 2015, 15, 877 , doi: 10.1186/s12889-015-2232-1.
-
Results
Kc A, Wrammert J, Nelin V, Ewald U, Clark R, Målqvist M, Level of mortality risk for babies born preterm or with a small weight for gestation in a tertiary hospital of Nepal, BMC Public Health, 2015, 15, 877, doi: 10.1186/s12889-015-2232-1.