ACTRN12623000600640招募中Unknown
Partnering Early to Provide for Infants At Risk of Cerebral palsy (PEPI ARC)- Evaluating the feasibility of implementing the New Zealand Best Practice Recommendations for Early diagnosis of Cerebral Palsy through a regional early diagnosis Hub.
Te Whatu Ora - Capital Coast District Health Board0 个研究点目标入组 100 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 2 Weeks 至 o limit（—）
- 性别
- All
入选标准
- •All infants admitted to Wellington NICU who meet the inclusion criteria and their parent/caregivers will be invited to participate in PEPI ARC. There are no limits placed on sample size and a formal sample size calculation is not required. The alternative option is to continue with standard care.
- •Eligibility
- •i.Admitted to the NICU at Wellington Regional Hospital.
- •ii.Survived until discharge from NICU.
- •iii.Discharge address located within the Wellington region or within one of Wellington NICU’s referral regions.
- •iv.Meet the Best Practice Recommendations criteria for risk of CP.
- •Inclusion criteria
- •1.Any Infant born less than 28+0 weeks gestation
- •2. Infant born at or after 28+0 weeks’ gestation with one or more detectable risk factors for CP:
- •i.Weight less than 1000 g.
- •ii.Intrauterine growth restriction.
- •Birth weight less than 3rd percentile on population-based or customized growth charts or at clinician’s discretion based on concern about pathological growth restriction.
- •iii.Abnormal findings on neuroimaging associated with CP.
- •(e.g., grade 3 and 4 intraventricular haemorrhage, post haemorrhagic ventricular dilatation, hydrocephalus, periventricular leukomalacia (PVL), stroke, brain maldevelopment).
- •iv.Grade 2 or 3 hypoxic ischaemic encephalopathy (HIE).
- •v.Neonatal encephalopathy of other aetiology.
- •vi.Neonatal meningitis/ encephalitis - bacterial or viral.
- •vii.Cardiac surgery.
- •viii.Clinical or parental concerns or other significant risk factor – clinician discretion
- •Surveys will be distributed to health professionals involved in the above infants care or seek information through contacting the Hub. Health professionals are not study participants.
排除标准
- •Exclusion Criteria
- •i.Infant born with a life limiting condition and not expected to survive past the first year of life.
- •ii.Whanau chose standard care.
- •iii.Infant and whanau discharge address is outside Wellington NICU’s catchment area or they are expected to move out of the catchment area before 3 months corrected gestational age.
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