NeoAdapt 2: An Observational Study Investigating Novel Biomarkers in the Evaluation and Treatment of Neonatal Circulatory Insufficiency in Infants Older Than 33 Weeks Gestational Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Superior Vena Cava Flow (SVCF) in infants older than 33 weeks gestational age receiving intensive care
研究概览
简要总结
Circulatory failure can affect up to 50% of premature infants that are admitted to neonatal intensive care. This can be because their heart muscle is not developed enough to send blood to vital organs such as the brain. This can lead to severe short term problems such as kidney failure and contribute to poor long term development such as cerebral palsy. In addition babies born too early may need more time to adapt from a circulation that relies on the placenta in the womb to one that is self sufficient.
Doctors need to be able to accurately measure the blood supply in an infant. However there is no agreement on how best to do this. This makes decisions about when to treat an infant difficult. Doctors may use drugs such as dopamine or dobutamine to help a babies circulation. However these drugs have not been tested properly in babies older than 33 weeks gestation.
This study proposes to observe the way babies older than 33 weeks circulatory problems are treated in the first three days of life. In addition the study will look at two new measurements of a babies blood supply to see if they are a better measure of when an infant needs treatment. This will involve an ultrasound scan of the heart and measurement of the child's oxygen levels from a probe placed on their hand or leg. The study will also look at how the drug dobutamine is processed by babies. This will be done from two small extra blood tests. The aim of the study is to help clinicians refine the identification and treatment of circulatory failure in premature babies.
详细描述
Research has shown that there is large difference in how doctors treat this circulatory failure. This is because there is no agreed definition for this condition. By investigating new methods of assessing a babies circulatory status we intend to help create a new definition of circulatory failure which will in turn help doctors create further studies to identify infants with circulatory failure and find the best ways of treating this condition in babies. So far research in this area has been confined to babies born at less than 33 weeks gestation. We intend to extend the knowledge in the area to infants older that 33 weeks gestation.
Dobutamine is a drug that does not have a license for use in premature infants. In the future all new drugs will need to be studied in children before a license for them is given. In addition the European Community are encouraging that research is undertaken to look into the use of old drugs which are used in babies. As mentioned previously there is very little data to show how dobutamine is handled by babies and this study will contribute to new information on how this drug should be given to babies safely.
This is a pilot observational study in infants older than 33 weeks gestational age. The population will be observed for the diagnostic measures used to trigger treatment for circulatory failure. Treatment decisions will be made according to the preference of the responsible doctors. The treatment decision will be documented by the research team and the effect of that treatment on diagnostic measures will be recorded.
There will be an additional sub study involving those infants who receive dobutamine. This study will look at how the babies handle this drug.
WHAT WILL HAPPEN TO RESEARCH PARTICIPANTS
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates >33 weeks gestational age
- •Postnatal age <72 hours
- •Parental informed consent
- •Admitted to the neonatal intensive care unit
排除标准
- •Non-viability
- •Congenital hydrops or malformations likely to affect cardiovascular adaptation
- •Surgery planned within 72 hours of birth
- •Chromosomal anomalies
- •Informed consent form (ICF) not signed
结局指标
主要结局
Superior Vena Cava Flow (SVCF) in infants older than 33 weeks gestational age receiving intensive care
时间窗: Once a day for a maximum of three days after birth
After consent and enrolment, Echo-D will be performed as soon possible in the first 24 hours a babies life. Echo-D assessments will be repeated every 24 hours during the first 72 hours of postnatal life, whenever possible. This in this measurement over the first three days of life will be recorded.
Pleth Variability Index (PVI) in infants older than 33 weeks gestational age receiving intensive care
时间窗: Once a day for a maximum of three days after birth
After consent and enrolment, PVI will be performed as soon possible in the first 24 hours a babies life. PVI assessments will be repeated every 24 hours during the first 72 hours of postnatal life, whenever possible. The change in this measurement in the first three days of life will be recorded
Pharmacokinetic data for the elimination half life of dobutamine when it is used for circulatory failure in infants older than 33 weeks gestational age.
时间窗: If dobutamine is given to an infant in the first three days of life
If dobutamine is given to an infant in the first three days of life 2 blood samples will be taken for pharmacokinetic analysis of dobutamine to determine its elimination half life.
次要结局
- SVCF and PVI values correlation to each other and to parameters that assess circulatory status such as mean blood pressure and capillary refill time(Over the first 3 days of life)
- SVCF and PVI values relationship to clinical outcomes(Over the first three days of life)
- SVCF and PVI values and dobutamine treatment for circulatory failure(Over the first three days of life)
研究者
Dr Liam Mahoney
Clinical Research Fellow in Paediatrics
Brighton and Sussex University Hospitals NHS Trust