Asphyxia NeonatorumPhase 3NCT00097097
Neonatal Resuscitation in Zambia
A Phase 3 study testing Neonatal Resuscitation in people with Asphyxia Neonatorum and Neonatal Mortality, run by NICHD Global Network for Women's and Children's Health at 1 site in Zambia.
Trial summary
Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asphyxia Neonatorum, Neonatal Mortality, Hypoxic Ischemic Encephalopathy
- What is being tested?
- Neonatal Resuscitation
- Type of treatment
- Surgery or procedure
- How many people
- 40,000 participants
- Where
- 1 siteZambia
- Study dates
- Oct 2004to Nov 2006
- Phase
- Phase 3
- 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
- Live birth infants with birth weight ≥ 1500 g
- Infants who are born at participating health centers in Lusaka and Ndola, Zambia
- No lethal malformations
Who cannot join
- Stillbirths
- Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left sided congenital heart disease that will not be repaired)
- Any infant who is transported/brought to the center after delivery
Trial locations and contacts
1 site in 1 country.
About this study
Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.
Read the detailed description
Birth asphyxia (defined as "failure to initiate and sustain breathing at birth") has been identified by the World Health Organization (WHO) as the most frequent cause of early deaths worldwide, accounting for about 20% of neonatal mortality. Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from birth asphyxia, the WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. The Neonatal Resuscitation Program (NRP) has been universally accepted in the developed world but has had limited dissemination in many developing countries, including Zambia. The primary hypothesis of this study is that implementation of the combined Neonatal Resuscitation Program/WHO Essential Newborn Care (ENC) Program, compared to basic neonatal care education of health care providers (ENC only) will result in reduced neonatal 7-day mortality. This trial will be performed in two Zambian cities: Lusaka and Ndola. Training in data collection will be conducted in order to establish baseline data on mortality and asphyxia. Following this time period, all centers will receive the ENC training and continue to collect data for 7 months. The clinics will then receive NRP Training and collect data for a 12-month period.
The primary outcome will be a decrease in neonatal 7-day mortality following the NRP training when compared to the ENC-only time period. Secondary outcomes will include neonatal mortality due to perinatal asphyxia, mortality or hypoxic ischemic encephalopathy (HIE) at 7 days, need for advanced resuscitation, Apgar scores at 5 minutes, sustainability of the program, as well as providers' self efficacy, competence, and performance in neonatal resuscitation.
- Being tested
- Neonatal Resuscitation
- Keywords
- Asphyxia, Neonatal mortality, Neonatal morbidity, Hypoxic ischemic encephalopathy, Neurodevelopmental impairment, Neonatal resuscitation, Global Network, Zambia, Africa, Cerebral palsy, Child health, International
- Medical subject headings
- Asphyxia Neonatorum, Hypoxia-Ischemia, Brain, Asphyxia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal ResuscitationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal mortality at 7 days
Secondary outcomes (3)
Neonatal mortality due to perinatal asphyxia
Self efficacy, knowledge, performance, and competence in neonatal resuscitation
Apgar scores at 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2004 (estimated)
- Study startOct 2004
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asphyxia NeonatorumStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40,000 participants
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Waldemar A Carlo, MD, Principal investigator, University of Alabama at BirminghamElwyn Chomba, MBChB, DCH, MRCP, Principal investigator, University Teaching Hospital, Lusaka, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097097
- Sponsor's protocol ID
- GN 03
- Other IDs
- U01HD043464
- Status last verified
- Jul 2014
- First submitted
- 17 Nov 2004
- 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
- Neonatal Resuscitation in Zambia
- ClinicalTrials.gov ID
- NCT00097097
- Acronym / sponsor ID
- GN 03
- Keywords
- Asphyxia, Neonatal mortality, Neonatal morbidity, Hypoxic ischemic encephalopathy, Neurodevelopmental impairment, Neonatal resuscitation, Global Network, Zambia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40,000 participants
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Alabama at Birmingham
- Study start
- Oct 2004
- Study completion
- Nov 2006 (actual)
- First posted
- 18 Nov 2004 (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.
Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.
Detailed description
Birth asphyxia (defined as "failure to initiate and sustain breathing at birth") has been identified by the World Health Organization (WHO) as the most frequent cause of early deaths worldwide, accounting for about 20% of neonatal mortality. Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from birth asphyxia, the WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. The Neonatal Resuscitation Program (NRP) has been universally accepted in the developed world but has had limited dissemination in many developing countries, including Zambia. The primary hypothesis of this study is that implementation of the combined Neonatal Resuscitation Program/WHO Essential Newborn Care (ENC) Program, compared to basic neonatal care education of health care providers (ENC only) will result in reduced neonatal 7-day mortality. This trial will be performed in two Zambian cities: Lusaka and Ndola. Training in data collection will be conducted in order to establish baseline data on mortality and asphyxia. Following this time period, all centers will receive the ENC training and continue to collect data for 7 months. The clinics will then receive NRP Training and collect data for a 12-month period.
The primary outcome will be a decrease in neonatal 7-day mortality following the NRP training when compared to the ENC-only time period. Secondary outcomes will include neonatal mortality due to perinatal asphyxia, mortality or hypoxic ischemic encephalopathy (HIE) at 7 days, need for advanced resuscitation, Apgar scores at 5 minutes, sustainability of the program, as well as providers' self efficacy, competence, and performance in neonatal resuscitation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Live birth infants with birth weight ≥ 1500 g
- Infants who are born at participating health centers in Lusaka and Ndola, Zambia
- No lethal malformations
Key exclusion criteria (3 listed)
- Stillbirths
- Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left sided congenital heart disease that will not be repaired)
- Any infant who is transported/brought to the center after delivery
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 | Procedure or surgery | – |
Primary outcome
Neonatal mortality at 7 days
3 secondary outcomes
Neonatal mortality due to perinatal asphyxia
Self efficacy, knowledge, performance, and competence in neonatal resuscitation
Apgar scores at 5 minutes
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 Network for Women's and Children's Health ResearchLink provided by the sponsor.
- Research Triangle Institute InternationalLink provided by the sponsor.
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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.
Waldemar A Carlo, MD principal investigator
University of Alabama at Birmingham
Elwyn Chomba, MBChB, DCH, MRCP principal investigator
University Teaching Hospital, Lusaka, Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neonatal Resuscitation in people with Asphyxia Neonatorum and Neonatal Mortality, run by NICHD Global Network for Women's and Children's Health at 1 site in Zambia.
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 3 inclusion and 3 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 1 site in 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Neonatal mortality at 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.