icterus Jaundice
Conditions
Interventions
We will investigate two interventions:
1. TcB measurement as a non-invasive screening tool to identify jaundice.
2. Application of phototherapy in the birth centre.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The two interventions each have their own primary outcome. 1. TcB measurement The proportion of babies with severe hyperbilirubinaemia within 14 days of life. 2. Application of phototherapy in the birth centres The proportion of babies requiring hospital admission for hyperbilirubinaemia treatment within 14 days of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes (all assessed within the first 14 days of life) include: - highest TSB level. - proportion of babies having TSB quantified at any time point. - number of times blood taken for TSB quantification and levels of individual measurements. - number of times blood taken for TSB quantification before start of phototherapy. - number of times TcB is quantified and levels of individual measurements. - difference in TcB measurement at forehead and sternum (at same time point). - proportion of babies receiving phototherapy. - duration (hours) of phototherapy (if relevant). - proportion of babies having a TSB level above the exchange transfusion threshold.(4) - proportion of babies who actually received an exchange transfusion. - duration of hospital stay (if relevant). - number of transfers between PCBCs/hospitals. - number of times paediatrician consulted and outcome of consultation. - cost-effectiveness of both interventions. - experience of parents (based on a questionnaire, see Attachment 4). The diagnosis of kernicterus will be made by combining clinical signs and symptoms and additional investigations (e.g. cerebral ultrasound, MRI) in every infant who had a TSB level above the exchange transfusion threshold level. Kernicterus is usually not diagnosed within the first 14 days of life. To this end the medical records of these infants will be requested at the age of one year at the general practitioner or paediatrician in order to determine the proportion of babies having kernicterus. This is included in the patient information sheet and the IC form. For the group of babies in whom phototherapy should be initiated in the PCBC the following parameters will be reported as well: - The proportion of babies in whom phototherapy was initiated in the hospital, despite inclusion during the intervention period with phototherapy in the PCBC, including reasons for this hospital admission. - The proportion of babies requiring subsequent | — |
Countries
Netherlands
Outcome results
None listed