Infant, Newborn, DiseasesBeSurENCT05954975
Baby Sickness Evaluation
An observational study of Infant, Newborn, Diseases, run by Ilona C Narayen, MD pHD.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Infant, Newborn, Diseases
- What is being tested?
- BabyCheck and pulse oximetry
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Infants up to six months of age.
- Presenting with systemic illness (no injuries or traumata).
- Presenting at the emergency GP post of Leiderdorp.
Who cannot join
- 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.
About this study
Official title: Objective Assessment of Illness Severity of Infants Presented at the Emergency General Practitioner Post
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.
Read the detailed description
Young infants frequently visit general practitioners (GP) with acute pathology, such as infections. Assessing severity of illness in this group is often challenging, since the likelihood of serious illness in this group is low, deterioration of the clinical condition can occur more rapidly. Therefore, early recognition of pathology in young babies is pivotal.
The Netherlands Triage System (derived from the Manchester Triage System) is a reliable tool for both children and adults to decide if a patient should be seen by the GP. However, after presentation at the GP, a scoring system to assess illness severity in babies with a decision aid for referral to hospital, is currently lacking.
The BabyCheck is a scoring system developed and validated as a clinical checklist to assess young infants up to six months of age. The BabyCheck is validated in multiple low illness prevalent settings.
In addition, abnormal oxygen saturation and/or heart rate can be an early sign of infection, respiratory or circulatory pathology in infants. Since it is difficult to adequately judge oxygen saturation solely by skin colour, it is preferable to objectify this parameter via pulse oximetry (PO).
The aim of this study is to assess the feasibility of using BabyCheck and PO by GPs as an illness severity score for young infants < six months of age in order to aid the decision for referral to hospital.
- Conditions
- Infant, Newborn, Diseases
- Being tested
- BabyCheck and pulse oximetry
- Keywords
- Screening, BabyCheck, Pulse oximetry, Young infant
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BabyCheck and pulse oximetryCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Infants up to 6 months of age | Infants up to six months of age, presenting with systemic illness at the emergency GP post. Receives: Combination Product: BabyCheck and pulse oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Sensitivity and specificity of the combined BabyCheck-PO score
a referral to the pediatric department is assigned just if no treatment, diagnostic tools or follow up is performed in hospital, which could not have been performed at the GP post.
Measured: 6 months
Acceptability of GPs
- Was the combination of questions and pulse oximetry useful for assessing illness severity in this infant? [yes/no]
- Did the outcome of the scores influence your decision for referral? [yes/no]
- Do you have any comments for the reseaerchers? [open field]
Measured: 6 months
Acceptability of pediatricians
- Was the referral necessary or just? [yes/no]
- Was the referral possibly previously missed or too much delayed? [yes/no].
- Was the combination of BabyCheck and pulse oximetry useful in assessing illness severity in this infant? [yes/no]
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilona C Narayen, MD pHD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ilona C Narayen, MD pHD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954975
- Sponsor's protocol ID
- 132698
- Acronym
- BeSurE
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Illness Severity of Infants Presented at the Emergency General Practitioner Post
- ClinicalTrials.gov ID
- NCT05954975
- Acronym / sponsor ID
- BeSurE / 132698
- Conditions
- Infant, Newborn, Diseases
- Keywords
- Screening, BabyCheck, Pulse oximetry, Young infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Ilona C Narayen, MD pHDUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Young infants frequently visit general practitioners (GP) with acute pathology, such as infections. Assessing severity of illness in this group is often challenging, since the likelihood of serious illness in this group is low, deterioration of the clinical condition can occur more rapidly. Therefore, early recognition of pathology in young babies is pivotal.
The Netherlands Triage System (derived from the Manchester Triage System) is a reliable tool for both children and adults to decide if a patient should be seen by the GP. However, after presentation at the GP, a scoring system to assess illness severity in babies with a decision aid for referral to hospital, is currently lacking.
The BabyCheck is a scoring system developed and validated as a clinical checklist to assess young infants up to six months of age. The BabyCheck is validated in multiple low illness prevalent settings.
In addition, abnormal oxygen saturation and/or heart rate can be an early sign of infection, respiratory or circulatory pathology in infants. Since it is difficult to adequately judge oxygen saturation solely by skin colour, it is preferable to objectify this parameter via pulse oximetry (PO).
The aim of this study is to assess the feasibility of using BabyCheck and PO by GPs as an illness severity score for young infants < six months of age in order to aid the decision for referral to hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants up to 6 months of age | – | Combination Product: BabyCheck and pulse oximetryInfants up to six months of age, presenting with systemic illness at the emergency GP post. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Infants up to six months of age.
- Presenting with systemic illness (no injuries or traumata).
- Presenting at the emergency GP post of Leiderdorp.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BabyCheck and pulse oximetryThe 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. | Combination product | Infants up to 6 months of age |
Primary outcome
Feasibility
Time frame: 6 months
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.
3 secondary outcomes
Sensitivity and specificity of the combined BabyCheck-PO score
Time frame: 6 months
Acceptability of GPs
Time frame: 6 months
Acceptability of pediatricians
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Newborn, Diseases, run by Ilona C Narayen, MD pHD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.