Neonatal DeathNEONCT04093778
NEO-study, Newborn Emergency Outcome
A study testing Low dose high frequency training and Safe Delivery Phone Application in people with Neonatal Death, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Globally, 2.9 million newborn infants die within the first 28 day of life and 2.6 million babies are born dead, 1.3 million of these being alive at the onset of labor. Newborn health is part of the "unfinished agenda" and requires greater visibility in the post-2015 agenda and is a key priority, and a direct indicator… Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Neonatal Death
- What is being tested?
- Low dose high frequency training and Safe Delivery Phone Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2019to 16 Oct 2020
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All newborns and their mothers delivered at Wete District Hospital, Chake Chake District hospital and Mkoani District Hospital or Micheweni Cottage Hospital.
- All newborns <1 month admitted to either the maternity or paediatric department
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: NEO-study, Newborn Emergency Outcome - Innovative Strategies In Management of Newborn Emergencies in Low- and Middle-Income Countries
Globally, 2.9 million newborn infants die within the first 28 day of life and 2.6 million babies are born dead, 1.3 million of these being alive at the onset of labor. Newborn health is part of the "unfinished agenda" and requires greater visibility in the post-2015 agenda and is a key priority, and a direct indicator of progress of the SDG's which sets out a vision of a world in which there are no preventable deaths of newborns or stillbirths, where every birth is celebrated and babies not only survives, but thrives to reach their full potential. There is an urgent need for research strengthening neonatal care in low recourse settings, which the NEO-study aims to contribute to.
The aim of the NEO-study is to understand the direct and underlying determinants of sub-standard care and improve the quality of care using innovative technologies such as video recordings and animated clinical videos to strengthen decision making and management of emergencies in newborns.
Read more
Study design This is the study protocol for a 14-month quality improvement study involving all district level hospital and cottage level hospitals in Pemba, Zanzibar.
Methodology The first part of the study is a 10-week observational baseline where all district level hospital deliveries are included, and data collected about the pregnancy, delivery and delivery outcome.
The intervention is a 9-month period where we will facilitate a quality improvement cycle using Low Dose High Frequency training with the Safe Delivery App as an anchor point and facilitate the integration into clinical practice through the Safe Delivery Focal Points at each hospital. All staff in maternity, pediatric wards and outpatient clinics will receive training and be encouraged to use the Safe Delivery App on a weekly basis.
After the end of the intervention period the investigators will repeat the 10-week observational study in the same months the following year as the baseline study and the findings will be used to measure adherence to guidelines, quality of care and the impact on perinatal and neonatal morbidity and mortality.
The study population for the primary endpoint are all newborns and their mothers who will be delivered in one of the district or cottage hospitals and all newborns admitted to either the maternity or pediatric departments.
Time frame From September 2019 to October 2020.
Expected outcomes The NEO-study is anticipated to improve quality of care and significantly decrease perinatal and neonatal mortality.
Read the detailed description
The aim of the NEO study is to understand the direct and underlying determinants of sub-standard care and improve the quality of care using innovative technologies to strengthen decision making and management of newborn emergencies. The NEO-study builds on and add to established mHealth initiatives for maternal and child health in Zanzibar, Tanzania and Denmark.
This is the study protocol for a 14-month quality improvement study involving all district level hospitals and one cottage hospital (Chake Chake, Mkoani, Wete, Micheweni) in Pemba, Zanzibar. The protocol is developed in equal partnership between the research team from Public Health Laboratory, Ivo de Carneri and the research team from University Hospital Copenhagen (Rigshospitalet). The partnership between the two institutes have been long-term and long-standing for more than a decade. The first exploratory visits for the NEO-study was conducted in February 2016 and October 2017. On both visits the investigators held fruitful meetings with managements at all district level hospitals and the relevant departments; maternity, paediatric and outpatient clinics to ensure participatory commitment and involvement in the process and development of the project. The principals of the Paris Declaration on Aid Effectiveness are applied to the presented research protocol and the investigators have included the needs expressed by the local health system and changed the protocol in accordance with requests and necessities expressed [1]. The investigators have raised funds between the first exploratory meetings and the study has the necessary financial support from national and international donors. The investigators are continuing to raise funds for future collaborations and extension and expansion of the NEO-study.
The final version of the protocol has been developed by the international and local research teams during a three-month research stay at Public Health Laboratory, Ivo de Carneri, Pemba from February to May 2019. In this period, the investigators conducted meetings, hearing, direct and indirect observations and pilot-testing of tools and feasibility testing of method of choice to ensure participatory involvement and continuous support from hospital managements at all district level hospitals. Furthermore, the investigators have sought to involve clinical staff at relevant maternity, paediatric and outpatient departments by informal conversations during observatory days and the investigators will make continuous efforts of staff involvement; at all levels to create local ownership. The investigators have identified a local focal person at each department who can support the implementation and be part of the change. The investigators are exploring new ground with novel methods to capture and improve the quality of care, and therefore the investigators have pre-tested the feasibility, acceptability, technicality and limited-efficacy testing in the "Feasibility Study - The efficacy of Video Analysis as a Supplementary objective tool to Criterion Based Clinical Audit (CBCA) in Newborn Emergencies" (NO.ZAREC.02/APR/2019/20)
The investigators hope this research proposal can add to the unfinished agenda of neonatal mortality and morbidity and support health workers who are assisting women and their babies during labour, delivery and in the first month of life.
- Conditions
- Neonatal Death
- Being tested
- Low dose high frequency training and Safe Delivery Phone Application
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose high frequency training and Safe Delivery Phone ApplicationOther
The intervention period is a 9-month period where we will facilitate a quality improvement cycle using Low Dose High Frequency training with the Safe Delivery App as an anchor point and facilitate the integration into clinical practice through our Safe Delivery Focal Points at each hospital. All staff in maternity, paediatric wards and outpatient clinics will receive training and be encouraged to use the Safe Delivery App on a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| SDA intervention | Experimental | Low dose high frequency training of all health workers in maternity and pediatric ward and dissemination of a Safe Delivery Application Receives: Other: Low dose high frequency training and Safe Delivery Phone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal mortality
The primary outcome of perinatal mortality will be analysed using logistic regression analysis on the binary outcomes of perinatal mortality (yes or no).
Measured: Review after one year
Secondary outcomes (2)
Increases health workers knowledge
Statistical analysis will be planned in detail before start of this - and nobody will have access to the data before this detailed analysis plan has been approved by external statistician/review board
Measured: Review after one year
Increase clinical performance in newborn emergencies
The videos collected in the baseline will serve as baseline and adherence to guidelines between clinical performance in the baseline and post-study will be compared. Pre-specified criteria will be used for good performance and a scoring system will be developed. Three independent experts will agree on these. The evaluation and scoring of the video will be performed of two independent pediatricians.
.
Measured: Review after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start16 Sep 2019 (estimated)
- Primary completion16 Sep 2020 (estimated)
- Study completion16 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DeathStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post study of effect of training intervention on perinatal and neonatal survival and health workers skills and knowledge
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Responsible party
- Principal investigator, Dr. Charlotte Holm-Hansen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093778
- Sponsor's protocol ID
- 22950-01
- Acronym
- NEO
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEO-study, Newborn Emergency Outcome - Innovative Strategies In Management of Newborn Emergencies in Low- and Middle-Income Countries
- ClinicalTrials.gov ID
- NCT04093778
- Acronym / sponsor ID
- NEO / 22950-01
- Conditions
- Neonatal Death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Study start
- 16 Sep 2019 (estimated)
- Primary completion
- 16 Sep 2020 (estimated)
- Study completion
- 16 Oct 2020 (estimated)
- First posted
- 18 Sep 2019 (actual)
- 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.
Globally, 2.9 million newborn infants die within the first 28 day of life and 2.6 million babies are born dead, 1.3 million of these being alive at the onset of labor. Newborn health is part of the "unfinished agenda" and requires greater visibility in the post-2015 agenda and is a key priority, and a direct indicator of progress of the SDG's which sets out a vision of a world in which there are no preventable deaths of newborns or stillbirths, where every birth is celebrated and babies not only survives, but thrives to reach their full potential. There is an urgent need for research strengthening neonatal care in low recourse settings, which the NEO-study aims to contribute to.
The aim of the NEO-study is to understand the direct and underlying determinants of sub-standard care and improve the quality of care using innovative technologies such as video recordings and animated clinical videos to strengthen decision making and management of emergencies in newborns.
Study design This is the study protocol for a 14-month quality improvement study involving all district level hospital and cottage level hospitals in Pemba, Zanzibar.
Methodology The first part of the study is a 10-week observational baseline where all district level hospital deliveries are included, and data collected about the pregnancy, delivery and delivery outcome.
The intervention is a 9-month period where we will facilitate a quality improvement cycle using Low Dose High Frequency training with the Safe Delivery App as an anchor point and facilitate the integration into clinical practice through the Safe Delivery Focal Points at each hospital. All staff in maternity, pediatric wards and outpatient clinics will receive training and be encouraged to use the Safe Delivery App on a weekly basis.
After the end of the intervention period the investigators will repeat the 10-week observational study in the same months the following year as the baseline study and the findings will be used to measure adherence to guidelines, quality of care and the impact on perinatal and neonatal morbidity and mortality.
The study population for the primary endpoint are all newborns and their mothers who will be delivered in one of the district or cottage hospitals and all newborns admitted to either the maternity or pediatric departments.
Time frame From September 2019 to October 2020.
Expected outcomes The NEO-study is anticipated to improve quality of care and significantly decrease perinatal and neonatal mortality.
Detailed description
The aim of the NEO study is to understand the direct and underlying determinants of sub-standard care and improve the quality of care using innovative technologies to strengthen decision making and management of newborn emergencies. The NEO-study builds on and add to established mHealth initiatives for maternal and child health in Zanzibar, Tanzania and Denmark.
This is the study protocol for a 14-month quality improvement study involving all district level hospitals and one cottage hospital (Chake Chake, Mkoani, Wete, Micheweni) in Pemba, Zanzibar. The protocol is developed in equal partnership between the research team from Public Health Laboratory, Ivo de Carneri and the research team from University Hospital Copenhagen (Rigshospitalet). The partnership between the two institutes have been long-term and long-standing for more than a decade. The first exploratory visits for the NEO-study was conducted in February 2016 and October 2017. On both visits the investigators held fruitful meetings with managements at all district level hospitals and the relevant departments; maternity, paediatric and outpatient clinics to ensure participatory commitment and involvement in the process and development of the project. The principals of the Paris Declaration on Aid Effectiveness are applied to the presented research protocol and the investigators have included the needs expressed by the local health system and changed the protocol in accordance with requests and necessities expressed [1]. The investigators have raised funds between the first exploratory meetings and the study has the necessary financial support from national and international donors. The investigators are continuing to raise funds for future collaborations and extension and expansion of the NEO-study.
The final version of the protocol has been developed by the international and local research teams during a three-month research stay at Public Health Laboratory, Ivo de Carneri, Pemba from February to May 2019. In this period, the investigators conducted meetings, hearing, direct and indirect observations and pilot-testing of tools and feasibility testing of method of choice to ensure participatory involvement and continuous support from hospital managements at all district level hospitals. Furthermore, the investigators have sought to involve clinical staff at relevant maternity, paediatric and outpatient departments by informal conversations during observatory days and the investigators will make continuous efforts of staff involvement; at all levels to create local ownership. The investigators have identified a local focal person at each department who can support the implementation and be part of the change. The investigators are exploring new ground with novel methods to capture and improve the quality of care, and therefore the investigators have pre-tested the feasibility, acceptability, technicality and limited-efficacy testing in the "Feasibility Study - The efficacy of Video Analysis as a Supplementary objective tool to Criterion Based Clinical Audit (CBCA) in Newborn Emergencies" (NO.ZAREC.02/APR/2019/20)
The investigators hope this research proposal can add to the unfinished agenda of neonatal mortality and morbidity and support health workers who are assisting women and their babies during labour, delivery and in the first month of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post study of effect of training intervention on perinatal and neonatal survival and health workers skills and knowledge
| Arm | Type | Receives |
|---|---|---|
| SDA intervention | Experimental | Other: Low dose high frequency training and Safe Delivery Phone ApplicationLow dose high frequency training of all health workers in maternity and pediatric ward and dissemination of a Safe Delivery Application |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All newborns and their mothers delivered at Wete District Hospital, Chake Chake District hospital and Mkoani District Hospital or Micheweni Cottage Hospital.
- All newborns <1 month admitted to either the maternity or paediatric department
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Low dose high frequency training and Safe Delivery Phone ApplicationThe intervention period is a 9-month period where we will facilitate a quality improvement cycle using Low Dose High Frequency training with the Safe Delivery App as an anchor point and facilitate the integration into clinical practice through our Safe Delivery Focal Points at each hospital. All staff in maternity, paediatric wards and outpatient clinics will receive training and be encouraged to use the Safe Delivery App on a weekly basis. | Other | SDA intervention |
Primary outcome
Perinatal mortality
Time frame: Review after one year
The primary outcome of perinatal mortality will be analysed using logistic regression analysis on the binary outcomes of perinatal mortality (yes or no).
2 secondary outcomes
Increases health workers knowledge
Time frame: Review after one year
Increase clinical performance in newborn emergencies
Time frame: Review after one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcomes will be made available.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose high frequency training and Safe Delivery Phone Application in people with Neonatal Death, run by Copenhagen University Hospital, Rigshospitalet.
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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Holm-Hansen, M.D. (+4523967325, charlotte.carina.holm-hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal mortality (time frame: Review after one year). 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 18 Sep 2019.