NL-OMON56682招募中不适用
Evaluation of the safety, effectiveness and natural care approach of the Jauni phototherapy romper. - Jauni Care Study 1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •- Born at or after a gestational age of 38 weeks.
- •If after participation of six low-risk neonates, the independent expert has not
- •identified any safety issues and effectiveness seems plausible, the eligibility
- •criteria will be extended to also include neonates born between 36 and 38
- •weeks of gestation.
- •- Total bilirubin level above phototherapy treatment threshold, according to
- •the Dutch guideline or phototherapy indicated by a paediatrician.{[Dutch
- •Paediatric Society] Nederlandse Vereniging voor Kindergeneeskunde, 2023 #328}
- •- Older than 24 hours of postnatal age.
- •- No risk factors* applicable for the subject, according to Dutch
- •guideline.{[Dutch Paediatric Society] Nederlandse Vereniging voor
- •Kindergeneeskunde, 2023 #328}
- •*Risk factors - blood group antagonisms - other haemolytic disorders - asphyxia
- •(AS 5 min < 5 or umbilical cord pH < 7.0 - ill, drowsy, suspected
- •infection/sepsis - (albumin < 30 g/Ll, (if determined)
排除标准
- •- Conjugated hyperbilirubinaemia (indirect/conjugated bilirubin levels >10 µmol/
- •L or >20% of total bilirubin level, if known).
- •- Bilirubin level not higher than: ((phototherapy threshold + exchange
- •transfusion threshold) / 2). According to the Dutch guideline. Unless the
- •attending paediatrician decides otherwise based on clinical criteria.{[ Dutch
- •Paediatric Society] Nederlandse Vereniging voor Kindergeneeskunde, 2023
- •#328}>XX µmol/L above phototherapy treatment threshold.
- •- Neonates having any contraindication for the use of Jauni:
- •- Subjects with congenital erythropoietic porphyria or other
- •photosensitising disorders.
- •- Subjects under photosensitive medication.
- •- Subjects with skin conditions, categorised as unsuitable for an on-skin
- •treatment by a healthcare
- •professional.
- •- Subjects with fever.
- •- The healthcare provider considers the neonate not suitable for phototherapy
- •using Jauni (with reasons noted).
- •- Parents do not provide written informed consent.
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