Clinical trial

Objective Assessment of Illness Severity of Infants Presented at the Emergency General Practitioner Post

Name

132698

Description

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.

Trial arms

Trial start

2023-09-01

Estimated PCD

2024-03-01

Trial end

2024-05-01

Status

Not yet recruiting

Treatment

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.

Arms:

Infants up to 6 months of age

Size

1500

Primary endpoint

Feasibility

6 months

Eligibility criteria

Inclusion Criteria: * Infants up to six months of age. * Presenting with systemic illness (no injuries or traumata). * Presenting at the emergency GP post of Leiderdorp. Exclusion Criteria: * Infants up to six months of age, presenting with traumata or that are in a resuscitation setting. * Infants with referral to other hospitals than the Alrijne hospital. The location for referral is coded and available from the anonymized database of the emergency GP post. * Infant \< 1 month of age presenting with fever (body temperature \> 38.0 ⁰C), with or without unknown origin, since these infants should always be referred according to the national guidelines for GPs. * Infants \< 3 months of age presenting with fever of unknown origin (temperature \> 38.0 ⁰C), since these infants should always be referred according to the national guidelines for GPs.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1500, 'type': 'ESTIMATED'}}

Updated at

2023-07-20

1 organization

1 product

3 indications

Organization

Ilona C Narayen, MD PhD

Product

Indication

Indication

Indication