NEO-study, Newborn Emergency Outcome

NCT04093778 | Unknown DMC

• 1 other identifier: 22950-01
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Neonatal Death

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Increases health workers knowledge

  Review after one year

• Increase clinical performance in newborn emergencies

  Review after one year

Other Outcomes (9)

• Decreases neonatal morbidity

  Review after one year

• Increases health workers participation in the intervention

  Review after one year

• Newborn care in healthy newborns

  Review after one year

Study Arms (1)

SDA intervention

EXPERIMENTAL

Low dose high frequency training of all health workers in maternity and pediatric ward and dissemination of a Safe Delivery Application

Other: Low dose high frequency training and Safe Delivery Phone Application

Interventions

Low dose high frequency training and Safe Delivery Phone Application OTHER

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.

SDA intervention

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Public Health Laboratory Ivo de Carneri: collaborator

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Charlotte Holm-Hansen, M.D.

CONTACT

+4523967325; charlotte.carina.holm-hansen@regionh.dk

Anja Poulsen, M.D. Ph.d.

CONTACT

+4527597321; anja.poulsen01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator NEO-study, Ph.d.-student

Model Details: Pre-post study of effect of training intervention on perinatal and neonatal survival and health workers skills and knowledge

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 18, 2019
• Study Start: September 16, 2019
• Primary Completion: September 16, 2020
• Study Completion: October 16, 2020
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available for the research team from the end of the baseline until two years after the end of the study,