MortalityLUNESPNCT00518856
Lufwanyama Neonatal Survival Project
A study testing Neonatal resuscitation protocol in people with Mortality, run by Boston University.
Trial summary
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mortality
- What is being tested?
- Neonatal resuscitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,559 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- TBA trained in safe delivery;
- willing to sign informed consent; willing to be randomized; willing to adhere to study procedures
Who cannot join
- TBA living outside of Lufwanyama district
About this study
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.
Read the detailed description
This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia. 120 TBAs are randomized into intervention/control. Intervention TBAs receive NRP training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. Control TBAs continue according to prior standard of care. Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm.
- Conditions
- Mortality
- Being tested
- Neonatal resuscitation protocol, Standard of care
- Keywords
- birth asphyxia, neonatal sepsis, maternal to child transmission of HIV
- Medical subject headings
- Asphyxia Neonatorum, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal resuscitation protocolOther
training in neonatal resuscitation and sepsis identification early treatment
Standard of careOther
continued with current standard of care for birth attendants
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | TBAs who receive training and supplies for the intervention Receives: Other: Neonatal resuscitation protocol |
| control | Active comparator | TBAs continuing with current standard of practice Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: day 28
Secondary outcomes (4)
perinatal mortality
Measured: day zero
sepsis mortality
Measured: deaths between days 1-28
cost effectiveness
Measured: days 0-28
successful delivery of nevirapine prophylaxis to HIV exposed deliveries
Measured: day zero umbilical cord dried blood spot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University
- Investigators
- Christopher J Gill, MD MS, Principal investigator, Boston UniverstiyGrace Mazala, RN, Study director, Lufwanyama District Health Management Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518856
- Sponsor's protocol ID
- GHS-A-00-03-00020-00-4
- Acronym
- LUNESP
- Status last verified
- Mar 2011
- First submitted
- 20 Aug 2007
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gill CJ, Guerina NG, Mulenga C, Knapp AB, Mazala G, Hamer DH. Training Zambian traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival Project (LUNESP). Int J Gynaecol Obstet. 2012 Jul;118(1):77-82. doi: 10.1016/j.ijgo.2012.02.012. Epub 2012 Apr 27.
PubMed 22542215Gill CJ, Phiri-Mazala G, Guerina NG, Kasimba J, Mulenga C, MacLeod WB, Waitolo N, Knapp AB, Mirochnick M, Mazimba A, Fox MP, Sabin L, Seidenberg P, Simon JL, Hamer DH. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study. BMJ. 2011 Feb 3;342:d346. doi: 10.1136/bmj.d346.
PubMed 21292711
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lufwanyama Neonatal Survival Project
- ClinicalTrials.gov ID
- NCT00518856
- Acronym / sponsor ID
- LUNESP / GHS-A-00-03-00020-00-4
- Conditions
- Mortality
- Keywords
- birth asphyxia, neonatal sepsis, maternal to child transmission of HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,559 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Tufts University
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.
Detailed description
This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia. 120 TBAs are randomized into intervention/control. Intervention TBAs receive NRP training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. Control TBAs continue according to prior standard of care. Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Neonatal resuscitation protocolTBAs who receive training and supplies for the intervention |
| control | Active comparator | Other: Standard of careTBAs continuing with current standard of practice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- TBA trained in safe delivery;
- willing to sign informed consent; willing to be randomized; willing to adhere to study procedures
Key exclusion criteria (1 listed)
- TBA living outside of Lufwanyama district
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatal resuscitation protocoltraining in neonatal resuscitation and sepsis identification early treatment | Other | intervention |
| Standard of carecontinued with current standard of care for birth attendants | Other | control |
Primary outcome
mortality
Time frame: day 28
4 secondary outcomes
perinatal mortality
Time frame: day zero
sepsis mortality
Time frame: deaths between days 1-28
cost effectiveness
Time frame: days 0-28
successful delivery of nevirapine prophylaxis to HIV exposed deliveries
Time frame: day zero umbilical cord dried blood spot
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
- Derived from this study: PubMed 22542215Gill CJ, Guerina NG, Mulenga C, Knapp AB, Mazala G, Hamer DH. Training Zambian traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival Project (LUNESP). Int J Gynaecol Obstet. 2012 Jul;118(1):77-82. doi: 10.1016/j.ijgo.2012.02.012. Epub 2012 Apr 27.
- Derived from this study: PubMed 21292711Gill CJ, Phiri-Mazala G, Guerina NG, Kasimba J, Mulenga C, MacLeod WB, Waitolo N, Knapp AB, Mirochnick M, Mazimba A, Fox MP, Sabin L, Seidenberg P, Simon JL, Hamer DH. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study. BMJ. 2011 Feb 3;342:d346. doi: 10.1136/bmj.d346.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Gill, MD MS principal investigator
Boston Universtiy
Grace Mazala, RN study director
Lufwanyama District Health Management Team
Questions about this trial
What is this clinical trial studying?
A study testing Neonatal resuscitation protocol in people with Mortality, run by Boston University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518856, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011.