Condition category
Neonatal Diseases
Date applied
07/08/2012
Date assigned
15/08/2012
Last edited
05/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
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 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

01/07/2012

Overall trial end date

30/09/2013

Reason abandoned

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

http://www.uu.se/

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

Results - basic reporting

Publication summary

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

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.