Baby Sickness Evaluation

NCT05954975 | Unknown

• 1 other identifier: 132698
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Screening; BabyCheck; Pulse oximetry; Young infant

Outcome Measures

Primary Outcomes (1)

• Feasibility

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

  6 months

Secondary Outcomes (3)

• Sensitivity and specificity of the combined BabyCheck-PO score

  6 months

• Acceptability of GPs

  6 months

• Acceptability of pediatricians

  6 months

Study Arms (1)

Infants up to 6 months of age

Infants up to six months of age, presenting with systemic illness at the emergency GP post.

Combination Product: BabyCheck and pulse oximetry

Interventions

BabyCheck and pulse oximetry COMBINATION_PRODUCT

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.

Infants up to 6 months of age

Eligibility Criteria

• Age: 0 Months - 6 Months
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Our study population consists of infants up to six months of age, presenting with systemic (non-traumatic/surgical) illness at the emergency GP post.

You may qualify if:

• Infants up to six months of age.
• Presenting with systemic illness (no injuries or traumata).
• Presenting at the emergency GP post of Leiderdorp.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ilona C Narayen, MD pHD: lead

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatrician and principal investigator Ilona Narayen

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 20, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07