Implementing simplified Neonatal Resuscitation Protocol - Helping Baby Breathe at Birth (HBB) - in a tertiary level hospital in Nepal for improved perinatal survival
| ISRCTN | ISRCTN97846009 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97846009 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/08/2012
- Registration date
- 15/08/2012
- Last edited
- 14/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Population Service International
Shree Mahalaxmi Sadan
GPO Box 21976
Mahalaxmisthan
Lagankhel
Lalitpur
-
Nepal
| ashish.k.c@kbh.uu.se |
Study information
| Study design | Prospective cohort study with before and after design |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | The introduction of a simplified Neonatal Resuscitation Protocol (HBB) will significantly improve perinatal outcome and survival in the study setting. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2012 |
| Completion date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 28000 |
| Key inclusion criteria | All newborns delivered at Paropakar Maternity and Women's Hospital in Kathmandu, Nepal during study period |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/07/2012 |
| Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- Nepal
Study participating centre
-
Nepal
Sponsor information
University/education
Department of Women's and Children's Health
University Hospital
Uppsala
75185
Sweden
| Phone | +46 (0)18 471 00 00 |
|---|---|
| mats.malqvist@kbh.uu.se | |
| Website | http://www.uu.se/ |
"ROR" |
https://ror.org/048a87296 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Laerdal Foundation
- Location
- Norway
Government organisation / Universities (academic only)
- Alternative name(s)
- Uppsala University, UU_University, Uppsala Universitet, Sweden, UU
- Location
- Sweden
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/10/2012 | Yes | No | |
| Results article | results | 05/07/2015 | Yes | No | |
| Results article | results | 10/09/2015 | Yes | No | |
| Results article | results | 31/08/2016 | Yes | No | |
| Results article | results | 31/01/2018 | Yes | No |
Editorial Notes
14/02/2018: Publication reference added.
05/09/2016: Publication reference added.
15/04/2016: Publication reference added.
