NeoAdapt 3: Novel Biomarkers in the Evaluation of Neonatal Circulatory Insufficiency in Babies Suffering From Hypoxic Ischemic Encephalopathy

NCT02051894 | Completed

• 1 other identifier: IRAS: 145271
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic encephalopathy (HIE). Infants with this condition can suffer multiple organ problems. In particular it can affect how their hearts pump blood around their body thus leading to a poor blood supply to parts of their body such as the brain. This is known as circulatory failure and can contribute to poor long term outcomes such as cerebral palsy. To try and prevent brain damage these infants are treated with total body cooling, however this treatment can further effect how babies pump blood around the body, but also how drugs which may be used by in this condition are processed. In order to assess and treat this condition 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. Sometimes doctors may want to use drugs such as dobutamine or adrenaline but these drugs are unlicensed in babies. This study proposes to observe the way babies circulatory problems are treated in babies with HIE the in the first four days of life. In addition the study will look are 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 baby's oxygen levels from a probe placed on their hand. 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 babies with HIE.

Conditions

Circulatory Failure

Keywords

Neonates; Dobutamine; Superior Vena Cana Flow; Hypoxic Ischemic Encephalopathy; Pleth Variability Index

Outcome Measures

Primary Outcomes (3)

• Superior Vena Cava Flow (SVCF) in babys recieving total body cooling for Hypoxic Ischemic Encephalopathy

  After consent and enrolment, Echo-D assessments will be repeated every 24 of cooling treatment (first 72 hours of postnatal life) and once during the re-warming phase (typically taking 8 hours after cooling has finished). The change in this measurement over the cooling treatment will be recorded.

  Once a day for a maximum of three days after birth

• Pleth Variability Index (PVI) in infants undergoing total body cooling treatment for hypoxic ischemic encephalopathy

  After consent and enrolment PVI assessments will be repeated every 24 of cooling treatment (first 72 hours of postnatal life) and once during the re-warming phase (typically taking 8 hours after cooling has finished). The changes in the PVI measurements will be recorded over the course of cooling therapy.

  Once a day for a maximum of three days after birth

• Pharmacokinetic data for the emilmination half life of dobutamine when this drug is given for circulatory failure

  If dobutamine is given for circulatory insufficiency in the first three days of life 2 blood samples will be taken for pharmacokinetic analysis of dobutamine.

  If dobutamine is given to an infant in the first three days of life

Secondary Outcomes (3)

• SVCF and PVI values corrleation 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

Study Arms (1)

HIE Group

Drug: Dobutamine

Interventions

Dobutamine DRUG

Infants will receive treatment according to the preference of the responsible physician. As is common practice, dobutamine, dopamine and/or other treatments (including other cardiovascular drugs and/or volume replacement therapy with normal saline) will be administered. If dobutamine is used we will take a maximum of two blood samples from the baby for pharmacokinetic analysis.

HIE Group

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants older than 36 weeks gestational age suffering from hypoxic ischemic encephalopathy receiving total body cooling

You may qualify if:

• Infants admitted to the NICU with HIE for total body cooling therapy
• Postnatal age \<72 hours
• Parental informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead
• European Union: collaborator

Study Sites (1)

Trevor Mann Baby Unit

Brighton, Sussex, BN2 5BE, United Kingdom

Location

Related Links

• This is the main clinical trial the study is associated with

Biospecimen

Retention: NONE RETAINED

Two blood samples of 400µl each will be obtained for each infant receiving dobutamine. Samples for the pharmacokinetic studies will utilise micro assays to minimise the amount of blood taken and will coincide with the taking of clinically indicated sample to reduce the burden placed on neonates included in this study.

MeSH Terms

Conditions

Shock; Hypoxia-Ischemia, Brain

Interventions

Dobutamine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Liam Mahoney, B

  Brighton & Sussex Medical School/Brighton & Sussex Universitys NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow in Paediatrics

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 31, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

GB (1)