The Newborn Early Warning System (NEWS)

January 31, 2022 updated by: PXL University College

The Newborn Early Warning Score: Een Mixed Method Onderzoek

Maternity wards record daily observations such as temperature, color, urine, faeces and weight of the newborn in the baby file. There is no structure and no uniformity in recording and interpreting them and in time to notify the doctor.

Adults who become ill, have clearly observable and interpretable signs such as fever, changed heart rate, and increasing pain symptoms. Verbal communication also contributes to timely risk assessment. In newborns, this is absent and vital parameters often remain good for some time despite deterioration in health status. Changes in behavior, micturition and weight can be a sign of infection or cardiopathy. Scientific studies show that in adults and children, signs of deterioration in health status are often not recognized and not acted immediately. (Paliwoda et al., 2016)

Early Warning Score Systems are used in several hospital settings with good results. ( Jensen et al., 2017; Alam et al., 2014) However, there is no universal scale that can be used for the entire hospital population. In newborns up to 120 hours postpartum, vital parameters such as heart rate, blood pressure, and saturation are currently not part of daily monitoring unlike in other hospital populations. Physical parameters such as color, micturation, weight and behavior can be a sign of decompensation and are not included in already existing measurement tools.

The healthcare industry has been very standardizing in recent years, which increases the need for a scientifically based tools tailored to the newborn.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

Problem Statement. Maternity wards record daily observations such as temperature, color, urine, stool and weight of the à terme newborn in the baby file. There is no structure and no uniformity in recording and interpreting these observations, nor in when the doctor should be notified.

In adults who become ill, there are clearly observable and interpretable signs such as fever, changed heart rate, and increasing pain symptoms. Verbal communication also contributes to timely risk assessment. In newborns, this is absent and vital parameters often remain good for some time despite deterioration in health status. Changes in behavior, micturition and weight can be a sign of infection or cardiopathy. Scientific studies show that in adults and children, signs of deterioration in health status are often not recognized and not acted upon in a timely manner. (Paliwoda et al., 2016) Early Warning Score Systems are used in several hospital settings with good results. ( Jensen et al., 2017; Alam et al., 2014) However, there is no universal scale that can be used for the entire hospital population. In à terme newborns up to 120 hours postpartum, vital parameters such as heart rate, blood pressure, and saturation are currently not part of daily monitoring unlike in other hospital populations. Physical parameters such as color, micturation, weight and behavior can be a sign of decompensation and are not included in already existing measurement tools.

The healthcare industry has been very standardizing in recent years, which increases the need for a scientifically based tool tailored to the newborn.

Methodology. In a first phase, a literature review will be performed to find out which parameters and trigger scores are essential in the early detection of problems in newborns up to 120 hours postpartum. A scientifically based tool will be developed to be tested, adjusted and validated in two Limburg maternities. In a before and after measurement, 20 midwives will be interviewed via semi-structured interviews about their findings before and after the use of the tool. From the medical records, information such as parameters, warning signals and time indicators will be collected and compared.

Expected Results. The research will result in descriptive statistics on the one hand, the feedback of info from the records and on the other hand from the qualitative analysis of the feedback from the interviews.

A third intended result is to present a validated Newborn Early Warning Score that can be used in the maternity department of several hospitals. This tool can also be implemented in the midwifery training to teach students how to register, interpret and report parameters of a newborn up to 120 hours postpartum in a structured way.

Study Type

Observational

Enrollment (Anticipated)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • PXL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A term Newborns max 120 hours old

Description

Inclusion Criteria:

  • newborn in the maternity ward

Exclusion Criteria:

  • premature baby's
  • ill baby's

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NEWS
Time Frame: 2 years
Newborn Early Warning Score
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

ZOL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Anticipated)

September 20, 2022

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • FRFO049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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