Circulatory Failure in Newborn InfantsNCT02047916
NeoAdapt 1: A Study of Circulatory Adaptation of Newborn Infants After Birth
An observational study of Circulatory Failure in Newborn Infants, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The current definitions of neonatal shock/circulatory failure are outdated and inaccurate. This makes the development of evidence based protocols for its treatment very difficult. Furthermore these definitions often rely on invasive methods of monitoring in patients such as an arterial line. Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Circulatory Failure in Newborn Infants
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Potential candidates for enrolment will be infants admitted to the postnatal ward for routine post natal care and those admitted to the Trevor Mann Baby Unit for special care. The infants will be greater than 33 weeks´ gestation, and postnatal age below 72 hours.
Who may be able to join
- Infant >33 weeks gestational age
- Postnatal age <72 hours;
- Parental informed consent;
- Infants receiving special care on the Trevor Mann Baby Unit or well babies on the postnatal ward
Who cannot join
- Neonates considered non-viable, with a clinical decision not to provide life support
- Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment
- Infants with congenital malformations likely to affect cardiovascular adaptation. These defects include congenital diaphragmatic hernia, gastroschisis or congenital heart defects.
- Infants in whom a surgical treatment is planned within 72 hours of birth
- Infants carrying chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
About this study
The current definitions of neonatal shock/circulatory failure are outdated and inaccurate. This makes the development of evidence based protocols for its treatment very difficult. Furthermore these definitions often rely on invasive methods of monitoring in patients such as an arterial line. Since the advent of functional echocardiography in neonatology there has been increased interest in non-invasive measurements of neonatal circulatory failure. However research in this field has been confined to premature infants.
The purpose of the this research is to look at non invasive methods of assessing an infants circulatory status in infants older than 33 weeks gestational age in order to fill the knowledge gap here and help in the development a new definition of neonatal circulatory failure.
Read the detailed description
Research has shown that the current definitions used by doctors to assess and treat infants who have a circulatory problem are inaccurate and lead to a large differences in how doctors treat this problem in babies. Treatments for circulatory problems in babies can involve the giving of medication such as adrenaline, dobutamine or dopamine. However these drugs are not licensed for use in babies and have potentially harmful side effects.
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 this area to infants older that 33 weeks gestation.
This is a pilot prospective observational study in babies older that 33 weeks. Infants will been considered to be from a healthy population (i.e. receiving routine care on the postnatal care or special care on the neonatal unit). Potential participants will be approached by a member of the research team and given information about the study and informed consent will be taken.
For the first three days of their lives all included infants will have two specific measurements once a day. These are known as:-
- Superior vena cava flow assessment- This involves measuring the blood flow through one of large veins that is connected to the babies' heart using an ultrasound machine. It is a painless procedure that is well tolerated by infants.
- Pleth variability index- This involves placing a small probe on the baby's hand or foot that will measure their oxygen levels. This will be done at the same time as the superior vena cava flow assessment is performed. Again this is a painless procedure that is well tolerated by infants.
Prior to these measurements the infants will have there blood pressure, heart rate, oxygen saturation's and capillary refill time assessed.
This assessments will be performed in addition to the routine care they receive. Infants will therefore have these measurements performed three times for the purpose of the study. If an infant is discharged by the clinical team before the third day of life then the measurements that have been performed prior to discharge will be included in the final analysis.
- Conditions
- Circulatory Failure in Newborn Infants
- Keywords
- Neonates, Superior Vena Cava Flow, Pleth variabilty index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Neonates > 33 weeks gestation | * Neonates >33 weeks gestational age * Postnatal age <72 hours; * Parental informed consent; * Inpatient at the Royal Sussex County Hospital (RCSH): either receiving special care on the Trevor Mann Baby Unit (TMBU) or normal care on the postnatal ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior Vena Cava Flow (SVC)
After consent and enrolment, Echo-D assessment for SVC flow will be performed as soon as possible after birth, preferably within 12 hours of birth. Echo D assessments will be repeated every 24 hours during the first 72 hours of postnatal life, whenever possible. We anticipate that it may only be possible to perform one set of measurements on an infant consented to the study. This is because many infants receiving postnatal or special care many infants will be discharged home before the age of 72 hours.
Measured: Once a day for a maximum of three days after birth
Pleth Variability Index (PVI)
After consent and enrolment, PVI assessments will be performed as soon as possible after birth, preferably within 12 hours of birth. PVI assessments will be repeated every 24 hours during the first 72 hours of postnatal life, whenever possible. We anticipate that it may only be possible to perform one set of measurements on an infant consented to the study. This is because many infants receiving postnatal or special care many infants will be discharged home before the age of 72 hours.
Measured: Once a day for a maximum of three days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory Failure in Newborn InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Dr Liam Mahoney, Brighton & Sussex Medical School
- Investigators
- Liam Mahoney, BMBS, MRCPCH, Principal investigator, Brighton & Sussex Medical School/Brighton & Sussex Universitys NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047916
- Sponsor's protocol ID
- IRAS 145159
- Status last verified
- Jul 2015
- First submitted
- 27 Jan 2014
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoAdapt 1: A Study of Circulatory Adaptation of Newborn Infants After Birth
- ClinicalTrials.gov ID
- NCT02047916
- Acronym / sponsor ID
- IRAS 145159
- Conditions
- Circulatory Failure in Newborn Infants
- Keywords
- Neonates, Superior Vena Cava Flow, Pleth variabilty index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current definitions of neonatal shock/circulatory failure are outdated and inaccurate. This makes the development of evidence based protocols for its treatment very difficult. Furthermore these definitions often rely on invasive methods of monitoring in patients such as an arterial line. Since the advent of functional echocardiography in neonatology there has been increased interest in non-invasive measurements of neonatal circulatory failure. However research in this field has been confined to premature infants.
The purpose of the this research is to look at non invasive methods of assessing an infants circulatory status in infants older than 33 weeks gestational age in order to fill the knowledge gap here and help in the development a new definition of neonatal circulatory failure.
Detailed description
Research has shown that the current definitions used by doctors to assess and treat infants who have a circulatory problem are inaccurate and lead to a large differences in how doctors treat this problem in babies. Treatments for circulatory problems in babies can involve the giving of medication such as adrenaline, dobutamine or dopamine. However these drugs are not licensed for use in babies and have potentially harmful side effects.
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 this area to infants older that 33 weeks gestation.
This is a pilot prospective observational study in babies older that 33 weeks. Infants will been considered to be from a healthy population (i.e. receiving routine care on the postnatal care or special care on the neonatal unit). Potential participants will be approached by a member of the research team and given information about the study and informed consent will be taken.
For the first three days of their lives all included infants will have two specific measurements once a day. These are known as:-
- Superior vena cava flow assessment- This involves measuring the blood flow through one of large veins that is connected to the babies' heart using an ultrasound machine. It is a painless procedure that is well tolerated by infants.
- Pleth variability index- This involves placing a small probe on the baby's hand or foot that will measure their oxygen levels. This will be done at the same time as the superior vena cava flow assessment is performed. Again this is a painless procedure that is well tolerated by infants.
Prior to these measurements the infants will have there blood pressure, heart rate, oxygen saturation's and capillary refill time assessed.
This assessments will be performed in addition to the routine care they receive. Infants will therefore have these measurements performed three times for the purpose of the study. If an infant is discharged by the clinical team before the third day of life then the measurements that have been performed prior to discharge will be included in the final analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Neonates > 33 weeks gestation | – | –* Neonates >33 weeks gestational age * Postnatal age <72 hours; * Parental informed consent; * Inpatient at the Royal Sussex County Hospital (RCSH): either receiving special care on the Trevor Mann Baby Unit (TMBU) or normal care on the postnatal ward |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Potential candidates for enrolment will be infants admitted to the postnatal ward for routine post natal care and those admitted to the Trevor Mann Baby Unit for special care. The infants will be greater than 33 weeks´ gestation, and postnatal age below 72 hours.
Key inclusion criteria (4 listed)
- Infant >33 weeks gestational age
- Postnatal age <72 hours;
- Parental informed consent;
- Infants receiving special care on the Trevor Mann Baby Unit or well babies on the postnatal ward
Key exclusion criteria (5 listed)
- Neonates considered non-viable, with a clinical decision not to provide life support
- Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment
- Infants with congenital malformations likely to affect cardiovascular adaptation. These defects include congenital diaphragmatic hernia, gastroschisis or congenital heart defects.
- Infants in whom a surgical treatment is planned within 72 hours of birth
- Infants carrying chromosomal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Superior Vena Cava Flow (SVC)
Time frame: Once a day for a maximum of three days after birth
After consent and enrolment, Echo-D assessment for SVC flow will be performed as soon as possible after birth, preferably within 12 hours of birth. Echo D assessments will be repeated every 24 hours during the first 72 hours of postnatal life, whenever possible. We anticipate that it may only be possible to perform one set of measurements on an infant consented to the study. This is because many infants receiving postnatal or special care many infants will be discharged home before the age of 72 hours.
Pleth Variability Index (PVI)
Time frame: Once a day for a maximum of three days after birth
After consent and enrolment, PVI assessments will be performed as soon as possible after birth, preferably within 12 hours of birth. PVI assessments will be repeated every 24 hours during the first 72 hours of postnatal life, whenever possible. We anticipate that it may only be possible to perform one set of measurements on an infant consented to the study. This is because many infants receiving postnatal or special care many infants will be discharged home before the age of 72 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- This is the main clinical trial the study is associated withLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Mahoney, BMBS, MRCPCH principal investigator
Brighton & Sussex Medical School/Brighton & Sussex Universitys NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory Failure in Newborn Infants, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superior Vena Cava Flow (SVC) (time frame: Once a day for a maximum of three days after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.