We hypothesise that among well neonates cared for at home during day 2-8 of life: 1. Universal TcB screening will improve recognition of neonates having hyperbilirubinaemia requiring treatment compared to visual inspection, while decreasing the need…
ID
Bron
Verkorte titel
Aandoening
Neonatal jaundice; neonatal hyperbilirubinemia; neonatal hyperbilirubinaemia; neonatale geelzucht; neonatale hyperbilirubinemie; neonatale icterus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary objective is to assess whether universal TcB screening can increase the detection of neonates with hyperbilirubinaemia necessitating treatment compared to using only visual inspection, and at the same time decrease the number of heel pricks performed to quantify total bilirubin in blood. As such, there are two primary endpoints assessed at each time point for each neonate:
(1) LBB above the treatment threshold
(2) the need for a heel prick to determine LBB.
Achtergrond van het onderzoek
Severely elevated bilirubin levels can place a neonate at risk for permanent brain damage, acute bilirubin encephalopathy or – on the long term – kern icterus spectrum disorder. Therefore, early diagnosis of severe neonatal hyperbilirubinemia (SNH) is essential to prevent these deleterious sequelae. Although known to be unreliable, visual inspection followed by selective laboratory-based bilirubin (LBB) quantification remains the current standard to prevent SNH in neonates cared for at home in the Netherlands. We aim to evaluate the effectiveness, diagnostic properties and cost-effectiveness of three novel approaches for screening and diagnosing neonatal hyperbilirubinemia in the home setting: transcutaneous bilirubinometer (TcB; Draeger JM-105), a smartphone app (Picterus®) and a point-of-care device for quantifying total bilirubin (Bilistick®).
Doel van het onderzoek
We hypothesise that among well neonates cared for at home during day 2-8 of life:
1. Universal TcB screening will improve recognition of neonates having hyperbilirubinaemia requiring treatment compared to visual inspection, while decreasing the need for heel pricks to quantify bilirubin in blood in case of suspected hyperbilirubinaemia.
2. The Picterus® app correlates well with TcB and laboratory-based bilirubin (LBB)levels and use of the Picterus® app will improve recognition of neonates having hyperbilirubinaemia necessitating treatment compared to visual inspection, while decreasing the need for heel pricks to quantify LBB.
3. In neonates requiring bilirubin quantification in blood, Bilistick® will have similar total bilirubin readings compared to LBB quantification, while reducing the time-to-test result to determine total bilirubin in blood.
Onderzoeksopzet
The primary outcomes and the secondary outcomes will be defined within the first 14 days of life of the neonate.
Onderzoeksproduct en/of interventie
1. Transcutaneous bilirubinometer (TcB; Draeger JM-105): a non-invasive method for estimating total bilirubin in blood
2. Picterus® app: a smartphone app which screens for neonatal jaundice using a photograph taken by a smartphone
3. Bilistick®: a commercially available point-of-care test for total bilirubin in whole blood
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Neonates are considered eligible for inclusion if they:
- are born at a gestational age of at least 35 weeks
- are cared for at home during day 2-8 of life
- have their first midwife visit at home prior to day 6
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Neonates are not considered eligible if they:
- previously received phototherapy
- Parents who have no sufficient understanding of the Dutch language to be able to understand the patient information sheet
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9545 |
| CCMO | NL74483.078.20 |
| OMON | NL-OMON55110 |