Condition category
Neonatal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Dr Ashish KC


Contact details

Population Service International
Shree Mahalaxmi Sadan
GPO Box 21976

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Perinatal mortality


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



Not Applicable

Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


Participant inclusion criteria

All newborns delivered at Paropakar Maternity and Women's Hospital in Kathmandu, Nepal during study period

Participant type


Age group




Target number of participants


Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Population Service International

Sponsor information


Uppsala University (Sweden)

Sponsor details

Department of Women's and Children's Health
University Hospital
+46 (0)18 471 00 00

Sponsor type




Funder type


Funder name

Laerdal Foundation (Norway)

Alternative name(s)

Laerdal Foundation

Funding Body Type

private sector organisation

Funding Body Subtype




Funder name

Uppsala Universitet

Alternative name(s)

Uppsala University

Funding Body Type

private sector organisation

Funding Body Subtype




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

2012 protocol in:
2015 results in:
2015 results in:
2015 results in:
2016 results in:

Publication citations

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes

05/09/2016: Publication reference added. 15/04/2016: Publication reference added.