Completed

Pediatric Acute Respiratory Distress Syndrome Bundle vs. Standard Care; a Before-and-After Study

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Lung Diseases+1

+ Respiration Disorders

+ Respiratory Distress Syndrome

Until 21 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2018
See protocol details

Summary

Principal SponsorKK Women's and Children's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 6, 2018

Actual date on which the first participant was enrolled.

We implement a PARDS ventilation bundle compliant with PALICC recommendations. The bundle contains a daily checklist for ventilation targets and reference tables listing targeted tidal volumes and end expiratory pressure-fraction of inspired oxygen titration. We will recruit mechanically ventilated patients who meet PARDS criteria. After a one-month implementation period, we will collect patient data over the subsequent 18 months, and compare them with the corresponding data in the 24 months prior to the implementation. The primary outcome is PARDS mortality, defined as number of deaths out of PARDS cases. Secondary outcomes are feasibility of ventilation bundle implementation, ventilator (VFD) and intensive care unit (IFD) free days and PICU mortality (number of deaths out of PICU admissions).

Official TitlePediatric Acute Respiratory Distress Syndrome Bundle vs. Standard Care; a Before-and-After Study
NCT03504176
Principal SponsorKK Women's and Children's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

134 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesRespiration DisordersRespiratory Distress SyndromeRespiratory Tract Diseases

Criteria

2 inclusion criteria required to participate
fulfill criteria for PARDS
mechanically ventilated
1 exclusion criteria prevent from participating
perinatal lung disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

KK Women's and Children's Hospital

Singapore, SingaporeOpen KK Women's and Children's Hospital in Google Maps
CompletedOne Study Center