NCT05234151

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

January 20, 2022

Last Update Submit

January 31, 2022

Conditions

Development Tool NEWS

Outcome Measures

Primary Outcomes (1)

  • NEWS

    Newborn Early Warning Score

    2 years

Interventions

NEWSOTHER

Newborn Early Warning Score

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A term Newborns max 120 hours old

You may qualify if:

  • newborn in the maternity ward

You may not qualify if:

  • premature baby's
  • ill baby's

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PXL

Hasselt, Limburg, 3500, Belgium

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 10, 2022

Study Start

September 20, 2021

Primary Completion

September 20, 2022

Study Completion

August 30, 2023

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)