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Baby Sickness Evaluation

NCT05954975 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2023-07-20

No results posted yet for this study

Summary

The goal of this prospective single center feasibility study is to assess the feasibility of using BabyCheck and PO by GPs as an illness severity score for young infants \> 6 months of age in order to aid the decision for referral to hospital.

The emergency GP posts in Leiderdorp will add the BabyCheck and PO to their standard evaluation of infants presenting with systemic illness \< six months of age for a period of six months.

The feasibility will be determined by calculating the percentage of eligible infants in whom a complete BabyCheck score and PO data were retrieved. The investigators consider the protocol feasible if this is done in 80% of all eligible infants.

Conditions

  • Infant, Newborn, Diseases

Interventions

COMBINATION_PRODUCT

BabyCheck and pulse oximetry

The BabyCheck is a validated scoring system to grade the severity of acute systemic illness in infants up to six months of age. Severity of illness is graded by using a weighted score of a combination of nineteen signs and symptoms. The higher the score, the higher the chance of severe illness. Nellcor PM10N is a pulse oximeter which is cleared for use in young infants. A sensor for infants will be used, so reliable oxygen saturation and heart rate can be obtained.

Sponsors & Collaborators

  • Ilona C Narayen, MD pHD

    lead OTHER

Eligibility

Min Age
0 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-03-31
Completion
2024-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05954975 on ClinicalTrials.gov