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

NCT02051894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2016-09-05

No results posted yet for this study

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

Interventions

DRUG

Dobutamine

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.

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Brighton and Sussex University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Liam Mahoney, B · Brighton & Sussex Medical School/Brighton & Sussex Universitys NHS Trust

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02051894 on ClinicalTrials.gov