Primary Objective: to assess the feasibility of the use of BabyCheck combined with standard PO for infants < six months of age presented at the emergency GP post. Secondary Objective(s): 1. To assess the sensitivity and specificity of the…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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..
Secondary outcome
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.
Acceptability of GPs will be assessed by asking three questions at the end of
the web-based data collection form:
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 researchers? [open field]
Acceptability of pediatricians/pediatric residents will be assessed by adding 3
questions in the electronic patient file at the BabyCheck field:
In the electronic patient file system, we will build three questions:
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 PO useful in assessing illness severity
in this infant? [yes/no]
Background summary
Young infants visit general practitioners (GP) frequently with acute pathology,
such as infections.1-4 Assessing severity of illness in this group is often
challenging, since many symptoms, such as crying and vomiting, can occur both
in mildly ill infants as well as in sicker infants.5-7 Deterioration of the
clinical condition can occur more rapidly, allthough the likelihood of serious
illness in this group is low,. 8 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. 9 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. Both unnecessary and
delayed referral are undesirable. Delayed referral of infants who are actually
severely ill may lead to delay in effective treatment and impede a favorable
outcome. Evaluation at the emergency department (ED) is time consuming for
parents, patients and health care providers. Also, the paediatric ED is
relatively cost-inefficient for low acuity concerns.10 In Great Britain, a
scoring system was developed and validated as a clinical checklist to quantify
the severity of illness in young infants up to six months of age. This scoring
system, called BabyCheck, contains nineteen signs and symptoms, grading the
severity of illness. The BabyCheck is validated in multiple low illness
prevalent settings.11-14 Also, it was considered as practical and manageable by
parents and GPs.15,16 A randomised controlled trial states that distribution of
BabyCheck booklets to an unselected group of mothers did not have effect on the
use of GP services for their infants. However, the authors also state that
BabyCheck might prove more valuable with a more thorough implementation
strategy.17 Low oxygen saturation (SpO2) can be an early sign of infection,
respiratory or circulatory pathology in infants.18,19 Since it is difficult to
adequately judge oxygen saturation solely by skin colour and obtaining heart
rate (HR) by auscultation is often inaccurate, it is preferable to objectify
these parameters via pulse oximetry (PO). These parameters could be useful to
decide whether referral is necessary, but also to decide which method of
transport to the ED is justifiable. However, pulse oximetry (PO) is rarely
performed by GPs in young infants, although it is widely used in older children
and adults. Most GP practices do not have an appropriate PO device or sensor
for young babies. (inventory survey among GPs). With this study we aim to
assess the feasibility of combining BabyCheck with standard PO for infants <
six months of age presented at the emergency GP post in order to aid the
decision for referral to the hospital.
Study objective
Primary Objective: to assess the feasibility of the use of BabyCheck combined
with standard PO for infants < six months of age presented at the emergency GP
post. Secondary Objective(s): 1. To assess the sensitivity and specificity of
the combination of BabyCheck and PO for just referral (treatment or diagnostic
in hospital, which would not have been possible in primary care setting) 2. To
assess GPs* acceptability of using BabyCheck and PO as a triage system for
sickness evaluation in young babies
Study design
This is a feasibility trial for a single center prospective trial performed at
the emergency GP post in Leiderdorp as well as at the pediatric department of
the Alrijne Hospital in Leiderdorp. The proposed triage system of BabyCheck
combined with PO will be assessed during a period of six months.
Study burden and risks
This research consist of a standard oxygen saturation and heart rate
measurement via a pulseoximetry and the calculation of the BabyCheck score
based on standard anamnesis and physical examination.
The BabyCheck is proven to be an effective tool to quantify the level of
sickness in babies. Pulseoximetry is a non-invasive test and measuring oxygen
saturation is considered standard of care in highrisk infants at birth
therefore widely used.
Even if the values from the pulseoximetry and BabyCheck don't give an
indication to refer to the pediatrician, the general practitioner is always
justified to consult a pediatrician. The responsibility to refer remains with
the general practitioner. It is therefore not expected that the research causes
harm to the infant.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Infants up to six months of age, presenting with systemic illness 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 *C), with or without unknown
origin, since these infants should always be referred according to the national
guidelines for GPs. [NHG richtlijn kinderen met koorts]. - Infants < 3 months
of age presenting with fever of uknown origin (temperature > 38.0 *C), since
these infants should always be referred according to the national guidelines
for GPs.[NHG richtlijn kinderen met koorts].
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05954975 |
| CCMO | NL84259.058.23 |