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NeoAdapt 2: An Observational Study Investigating Novel Biomarkers in the Evaluation and Treatment of Neonatal Circulatory Insufficiency

NCT02051855 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2016-07-19

No results posted yet for this study

Summary

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.

Conditions

  • Circulatory Failure

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Brighton and Sussex University Hospitals NHS Trust

    lead OTHER

Principal Investigators

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

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United Kingdom

Study Locations

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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 NCT02051855 on ClinicalTrials.gov