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on-invasive diagnosis and treatment of neonatal jaundice in primary care

Recruiting
Conditions
icterus
Jaundice
10019654
10028920
Registration Number
NL-OMON55558
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
5500
Inclusion Criteria

Babies are eligible if:
- They were born after 35 completed weeks of gestation.
- They are admitted in a participating PCBC during the study period within the
first week of life.
- They are expected to remain admitted for at least two days (so as to allow
for serial TcB measurements to take place).
- Signed informed consent (IC) is available from parent(s)

Exclusion Criteria

Babies are not eligible if:
- They previously received phototherapy (reliability of TcB measurement is
reduced in babies who are receiving or have received phototherapy).
- They have large congenital anomalies at the sternum or forehead.
- Parents do not have sufficient understanding of the Dutch language to be able
to comprehend the patient information sheet.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The two interventions each have their own primary outcome.<br /><br>1. TcB measurement<br /><br>The proportion of babies with severe hyperbilirubinaemia within 14 days of<br /><br>life.<br /><br>2. Application of phototherapy in the birth centres<br /><br>The proportion of babies requiring hospital admission for hyperbilirubinaemia<br /><br>treatment within 14 days of life.</p><br>
Secondary Outcome Measures
NameTimeMethod
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