NEO-study, Newborn Emergency Outcome

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

Interventions

OTHER

Low dose high frequency training and Safe Delivery Phone Application

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.

Sponsors & Collaborators

• Public Health Laboratory Ivo de Carneri

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-16

Primary Completion

2020-09-16

Completion

2020-10-16