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Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Updated: Nov 15, 2025

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Published on: August 25, 2014

A composite neonatal adverse outcome indicator using population-based data: an update.

S Todd^1,2,3, J Bowen^1,2,4, I Ibiebele^1,2

¹The University of Sydney Northern Clinical School, Women and Babies Research, St Leonards, NSW 2065, Australia.

International Journal of Population Data Science

|March 1, 2021

Summary

This summary is machine-generated.

An updated composite indicator effectively identifies severe neonatal morbidity using linked data. This tool aids in monitoring perinatal quality and safety, showing increased morbidity rates over time and significant risks for infants.

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Area of Science:

Neonatal Medicine
Public Health Surveillance
Health Informatics

Background:

Routinely collected, linked retrospective data offer a cost-effective method for estimating severe neonatal morbidity rates.
This approach is crucial for monitoring the quality and safety of perinatal services.
Updates to coding systems necessitate revising existing composite neonatal adverse outcome indicators.

Purpose of the Study:

To update the composite neonatal adverse outcome indicator for identifying neonates with severe or medically significant morbidity.
To validate the updated indicator's concurrent and predictive capabilities.

Main Methods:

Expert clinician input and audit of diagnosis/procedure codes were used to update the indicator's components.
Linked birth, hospital, and death data from New South Wales, Australia (2002-2014) were analyzed.
The study included live births at 24 weeks or more gestation.

Main Results:

The updated indicator comprises 28 diagnostic and procedure components.
In 1,194,681 live births, 5.44% experienced neonatal morbidity, with rates varying by gestational age and increasing over time.
Severe neonatal morbidity was linked to a doubled risk of hospital readmission and a tenfold increased risk of first-year mortality.

Conclusions:

The updated composite indicator demonstrates maintained concurrent and predictive validity.
It serves as a standardized and economical tool for measuring neonatal morbidity in population-based data.
Consideration of changes in individual components is important for longitudinal data analysis.