Perinatal MortalityPhase 4VANCT00640055
Verbal Autopsy to Assess Early Neonatal Death and Stillbirth
A Phase 4 study testing Coordinator and Physician-assigned cause of death in people with Perinatal Mortality and Cause of Neonatal Death, run by NICHD Global Network for Women's and Children's Health at 4 sites in 4 countries.
Trial summary
The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site, international research network, provides a unique infrastructure to implement an expanded perinatal verbal autopsy study using the FIRST BREATH trial as its platform. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Perinatal Mortality, Cause of Neonatal Death, Cause of Stilbirth
- What is being tested?
- Coordinator and Physician-assigned cause of death
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2007to Jul 2008
- Phase
- Phase 4
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonatal death with 7-days or stillbirth
- Lives in study cluster
Who cannot join
- Mother died
- Delivery in hospital setting
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa
About this study
Official title: Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network
The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site, international research network, provides a unique infrastructure to implement an expanded perinatal verbal autopsy study using the FIRST BREATH trial as its platform. The FIRST BREATH trial is an ongoing study of neonatal resuscitation training in rural community settings within Global Network sites in Central Africa, Asia and Latin America.
This study uses a validated VA questionnaire to determine COD of stillbirths and early neonatal deaths among participants in the FIRST BREATH study. We propose to expand the usefulness of perinatal verbal autopsy methodology in two ways. First by assessing whether the Community Coordinator (a non-physician health worker) can assign COD with a high level of concordance comparable to a Physician Panel, and second, whether the FIRST BREATH Birth Attendant can provide as reliable perinatal information as the mother during the VA interview. Our primary hypothesis is that the COD assigned by the FIRST BREATH Community Coordinator will be the same as the COD assigned by the Physician Panel in greater than 70% of early neonatal deaths (ENDs), when both use the same VA and FIRST BREATH data.
- Being tested
- Coordinator, Physician-assigned cause of death
- Keywords
- verbal autopsy, stillbirth, neonatal death
- Medical subject headings
- Perinatal Death, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoordinatorOther
Coordinator (non-physician) assigned cause of death
Physician-assigned cause of deathOther
Physician (gold standard) cause of death
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Coordinator (non-physician) Receives: Other: Coordinator |
| 2 | Placebo comparator | Physician Receives: Other: Physician-assigned cause of death |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel
Measured: 7-days
Secondary outcomes (2)
The COD for stillbirth as assigned by the Community Coordinator compared to the COD for stillbirth as assigned by the Physician Panel
Measured: 7 days
The agreement between mothers' and birth attendants' responses on selected items on the VA questionnaire (considering the mothers' response as the reference standard).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marion Koso-Thomas, MD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Cyril Engmann, Principal investigator, UNC at CHapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640055
- Sponsor's protocol ID
- CP03
- Other IDs
- U01HD040636
- Acronym
- VA
- Status last verified
- Jul 2014
- First submitted
- 18 Mar 2008
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network
- ClinicalTrials.gov ID
- NCT00640055
- Acronym / sponsor ID
- VA / CP03
- Keywords
- verbal autopsy, stillbirth, neonatal death
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Mar 2008 (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.
The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site, international research network, provides a unique infrastructure to implement an expanded perinatal verbal autopsy study using the FIRST BREATH trial as its platform. The FIRST BREATH trial is an ongoing study of neonatal resuscitation training in rural community settings within Global Network sites in Central Africa, Asia and Latin America.
This study uses a validated VA questionnaire to determine COD of stillbirths and early neonatal deaths among participants in the FIRST BREATH study. We propose to expand the usefulness of perinatal verbal autopsy methodology in two ways. First by assessing whether the Community Coordinator (a non-physician health worker) can assign COD with a high level of concordance comparable to a Physician Panel, and second, whether the FIRST BREATH Birth Attendant can provide as reliable perinatal information as the mother during the VA interview. Our primary hypothesis is that the COD assigned by the FIRST BREATH Community Coordinator will be the same as the COD assigned by the Physician Panel in greater than 70% of early neonatal deaths (ENDs), when both use the same VA and FIRST BREATH data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: CoordinatorCoordinator (non-physician) |
| 2 | Placebo comparator | Other: Physician-assigned cause of deathPhysician |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neonatal death with 7-days or stillbirth
- Lives in study cluster
Key exclusion criteria (2 listed)
- Mother died
- Delivery in hospital setting
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 |
|---|---|---|
| CoordinatorCoordinator (non-physician) assigned cause of death | Other | 1 |
| Physician-assigned cause of deathPhysician (gold standard) cause of death | Other | 2 |
Primary outcome
Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel
Time frame: 7-days
2 secondary outcomes
The COD for stillbirth as assigned by the Community Coordinator compared to the COD for stillbirth as assigned by the Physician Panel
Time frame: 7 days
The agreement between mothers' and birth attendants' responses on selected items on the VA questionnaire (considering the mothers' response as the reference standard).
Time frame: 7 days
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 Jul 2014.
- Global NetworkLink provided by the sponsor.
Related trials for Perinatal Mortality
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Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
Not yet recruiting
When Death Is Present at Birth: Women's Experiences During Pregnancy
Pregnancy
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
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.
Marion Koso-Thomas, MD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cyril Engmann principal investigator
UNC at CHapel Hill
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coordinator and Physician-assigned cause of death in people with Perinatal Mortality and Cause of Neonatal Death, run by NICHD Global Network for Women's and Children's Health at 4 sites in 4 countries.
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 2 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Guatemala, Pakistan, Republic of the Congo, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel (time frame: 7-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2014.