Neonatal Death Clinical Trial
— NEOOfficial 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.
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.
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | October 16, 2020 |
Est. primary completion date | September 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Month |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Public Health Laboratory Ivo de Carneri |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Decreases neonatal morbidity | This outcome will be measured when the mother receives a phone call at 1, 7 and 28 days post-partum. | Review after one year | |
Other | Increases health workers participation in the intervention | This outcome will be assessed using qualitative interviews before and after the intervention. | Review after one year | |
Other | Newborn care in healthy newborns | Statistical analysis will be planned in detail before start of the analysis - and nobody will have access to the data before this detailed analysis plan has been approved by external statistician/review board | Review after one year | |
Other | Improves quality of care of newborn emergencies | 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 | Review after one year | |
Other | Early neonatal mortality | The outcome of early neonatal mortality will be analysed using logistic regression analysis on the binary outcomes of early neonatal mortality (yes or no). | Review after one year | |
Other | ? Late neonatal mortality | The outcome of late neonatal mortality will be analysed using logistic regression analysis on the binary outcomes of late neonatal mortality (yes or no). | Review after one year | |
Other | ? Health worker perceptions of the intervention | This outcome will be assessed using qualitative semi-structured interviews of health workers. | Review after one year | |
Other | ? Mother perceptions of the intervention | This outcome will be assessed using qualitative semi-structured interviews of mothers. | Review after one year | |
Other | ? Indirect impact on care during labour and delivery | This measure will see if the intervention indirectly improves the quality of care during labour, e.g. observation of heart rate and blood pressure, management of hypertensive disorders in pregnancy including preeclampsia. We will fill forms in the baseline and the post study form the mothers from their forms and see if a registration of heart rate and blood pressure has taken place. We will also register the value blood pressure taken. If above 140/90 we will register how many of the women was checked for preeclampsia (proteinuria). 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. 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 |
Review after one year | |
Primary | 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). | Review after one year | |
Secondary | 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 | Review after one year | |
Secondary | 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. . |
Review after one year |
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