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

NCT02051855 | Completed

• 1 other identifier: IRAS: 145205
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neonates; Superior Vena Cava Flow; Pleth Variability Index; Dobutamine; Intensive Care

Outcome Measures

Primary Outcomes (3)

• Superior Vena Cava Flow (SVCF) in infants older than 33 weeks gestational age receiving intensive care

  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.

  Once a day for a maximum of three days after birth

• Pleth Variability Index (PVI) in infants older than 33 weeks gestational age receiving intensive care

  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

  Once a day for a maximum of three days after birth

• Pharmacokinetic data for the elimination half life of dobutamine when it is used for circulatory failure in infants older than 33 weeks gestational age.

  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.

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

Secondary Outcomes (3)

• 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

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 aged older than 33 weeks gestational admitted to the neonatal intensive care unit

You may qualify if:

• Neonates \>33 weeks gestational age
• Postnatal age \<72 hours
• Parental informed consent
• Admitted to the neonatal intensive care unit

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

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liam Mahoney, BMBS, MRCPCH

  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: July 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

GB (1)