An observational study in Infant, Newborn, Diseases, sponsored by Ilona C Narayen, MD pHD. Status unknown. Open to participants aged 0 Months to 6 Months. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by Ilona C Narayen, MD pHD · Observational
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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.
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.
140 studies on the registry are indexed under Infant, Newborn, Diseases; 29 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 100 across 49 observational studies indexed under Infant, Newborn, Diseases.
Browse Infant, Newborn, Diseases studies →This is the only study on the registry with Ilona C Narayen, MD pHD as lead sponsor.
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Our study population consists of infants up to six months of age, presenting with systemic (non-traumatic/surgical) illness at the emergency GP post.
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Exclusion Criteria:
Infants up to six months of age, presenting with systemic illness at the emergency GP post.
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.
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.
Time frame: 6 months
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.
Time frame: 6 months
Acceptability of GPs
1. Was the combination of questions and pulse oximetry useful for assessing illness severity in this infant? \[yes/no\] 2. Did the outcome of the scores influence your decision for referral? \[yes/no\] 3. Do you have any comments for the reseaerchers? \[open field\]
Time frame: 6 months
Acceptability of pediatricians
1. Was the referral necessary or just? \[yes/no\] 2. Was the referral possibly previously missed or too much delayed? \[yes/no\]. 3. Was the combination of BabyCheck and pulse oximetry useful in assessing illness severity in this infant? \[yes/no\]
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2023; primary completion for Mar 2024, 6 months later.
Of 32 observational studies under Infant, Newborn, Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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