InfantNeo-vitalNCT06032494
Investigating Changes in Vital Signs in Neonates
An observational study of Infant and Newborn, run by University of Oxford at 1 site in United Kingdom.
Trial summary
1 in 7 babies require neonatal care. During their time in hospital their vital signs (such as heart rate, breathing rate and oxygen saturation) are continuously monitored as part of standard care. Read more about this study
- Who is it for?
- Ages Up to 42 weeks
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2023to 1 Sep 2024
- 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 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: This single-centre prospective observational exploratory study will take place at the John Radcliffe Hospital, Oxford. Participants will be infants receiving inpatient care on the Newborn Care Unit.
Who may be able to join
- Infants will be eligible to be included in the study if they are:
- Born to, or expected to be born to, a mother aged 16 or over
- Admitted to the Newborn Care Unit, John Radcliffe Hospital, or anticipated delivery of a baby who will require admittance to the Newborn Care Unit at birth
- Mother given informed written consent
Who cannot join
- Infants will be ineligible if the following exclusion criteria applies:
- Known chromosomal abnormality or life-threatening congenital abnormality
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital
Oxford, OX14 3XL
Caroline Hartley, PhD, +44 1865 234537, caroline.hartley@paediatrics.ox.ac.uk
About this study
Official title: Neo-vital: Investigating Changes in Vital Signs in Neonates
1 in 7 babies require neonatal care. During their time in hospital their vital signs (such as heart rate, breathing rate and oxygen saturation) are continuously monitored as part of standard care. Many factors lead to changes in vital signs, for example, medical procedures such as blood tests can result in brief increases in heart rate. Medication can also alter vital signs, either as an intended effect or as a side effect. However, different infants will respond in different ways to both procedures and medication. Predicting how an individual infant may respond could lead to better individualised care for infants. For example, using an infant's baseline vital signs to predict whether they will experience cardiorespiratory side effects from a particular drug could mean that doctors could choose an alternative safer treatment plan. To develop these predictive models, it is essential to first better understand how infants' vital signs are affected by different procedures and drugs, and how these effects are impacted by other factors such as infection, other pathologies, interaction between drugs and age.
Despite their routine use in hospital neonatal units, detailed electronic records of vital signs are often not recorded. Often, only major events or average values are stated on clinical records. Subtle changes in vital signs are therefore missed, and more complex analysis that may reveal important predictive features within the data is not possible. In this study the investigators will electronically record infant vital signs across longer time periods and during a variety of clinically-necessary procedures and administration of drugs, to explore how these impact vital signs and are altered by factors such as age and pathology. These will be compared with control procedures, such as a nappy change, or when the infant is resting in their cot or receiving skin-to-skin care.
- Keywords
- preterm, respiration, oxygen saturation, heart rate
- Medical subject headings
- Premature Birth, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate following drug administration
To characterise the change in heart rate in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
Measured: 1 day after drug administration, compared with baseline of 1 day before drug administration.
Change in oxygen saturation following drug administration
To characterise the change in oxygen saturation in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
Measured: 1 day after drug administration, compared with baseline of 1 day before drug administration.
Change in respiratory rate following drug administration
To characterise the change in heart rate in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
Measured: 1 day after drug administration, compared with baseline of 1 day before drug administration.
Change in heart rate following procedures
To characterise the change in heart rate in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
Measured: 1 day after procedure, compared with baseline of 1 day before procedure.
Change in oxygen saturation following procedures
To characterise the change in oxygen saturation in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
Measured: 1 day after procedure, compared with baseline of 1 day before procedure.
Change in respiratory rate following procedures
To characterise the change in respiratory rate in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
Measured: 1 day after procedure, compared with baseline of 1 day before procedure.
Secondary outcomes (2)
Models of drug response
Prediction of drug regimen requirements in individual infants from respiratory rate.
Measured: 1 day after drug administration, compared with baseline of 1 day before drug administration.
Models of procedure response
Prediction of procedure outcome in individual infants (e.g. extubation success) from respiratory rate
Measured: 1 day after procedure, compared with baseline of 1 day before procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start20 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032494
- Sponsor's protocol ID
- PID16761
- Acronym
- Neo-vital
- Status last verified
- Dec 2023
- First submitted
- 9 Aug 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-vital: Investigating Changes in Vital Signs in Neonates
- ClinicalTrials.gov ID
- NCT06032494
- Acronym / sponsor ID
- Neo-vital / PID16761
- Keywords
- preterm, respiration, oxygen saturation, heart rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 13 Sep 2023 (actual)
- 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.
1 in 7 babies require neonatal care. During their time in hospital their vital signs (such as heart rate, breathing rate and oxygen saturation) are continuously monitored as part of standard care. Many factors lead to changes in vital signs, for example, medical procedures such as blood tests can result in brief increases in heart rate. Medication can also alter vital signs, either as an intended effect or as a side effect. However, different infants will respond in different ways to both procedures and medication. Predicting how an individual infant may respond could lead to better individualised care for infants. For example, using an infant's baseline vital signs to predict whether they will experience cardiorespiratory side effects from a particular drug could mean that doctors could choose an alternative safer treatment plan. To develop these predictive models, it is essential to first better understand how infants' vital signs are affected by different procedures and drugs, and how these effects are impacted by other factors such as infection, other pathologies, interaction between drugs and age.
Despite their routine use in hospital neonatal units, detailed electronic records of vital signs are often not recorded. Often, only major events or average values are stated on clinical records. Subtle changes in vital signs are therefore missed, and more complex analysis that may reveal important predictive features within the data is not possible. In this study the investigators will electronically record infant vital signs across longer time periods and during a variety of clinically-necessary procedures and administration of drugs, to explore how these impact vital signs and are altered by factors such as age and pathology. These will be compared with control procedures, such as a nappy change, or when the infant is resting in their cot or receiving skin-to-skin care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This single-centre prospective observational exploratory study will take place at the John Radcliffe Hospital, Oxford. Participants will be infants receiving inpatient care on the Newborn Care Unit.
Key inclusion criteria (4 listed)
- Born to, or expected to be born to, a mother aged 16 or over
- Admitted to the Newborn Care Unit, John Radcliffe Hospital, or anticipated delivery of a baby who will require admittance to the Newborn Care Unit at birth
- Mother given informed written consent
Key exclusion criteria (2 listed)
- Known chromosomal abnormality or life-threatening congenital abnormality
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
Change in heart rate following drug administration
Time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
To characterise the change in heart rate in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
Change in oxygen saturation following drug administration
Time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
To characterise the change in oxygen saturation in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
Change in respiratory rate following drug administration
Time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
To characterise the change in heart rate in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
Change in heart rate following procedures
Time frame: 1 day after procedure, compared with baseline of 1 day before procedure.
To characterise the change in heart rate in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
Change in oxygen saturation following procedures
Time frame: 1 day after procedure, compared with baseline of 1 day before procedure.
To characterise the change in oxygen saturation in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
Change in respiratory rate following procedures
Time frame: 1 day after procedure, compared with baseline of 1 day before procedure.
To characterise the change in respiratory rate in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
2 secondary outcomes
Models of drug response
Time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
Models of procedure response
Time frame: 1 day after procedure, compared with baseline of 1 day before procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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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.
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 Infant and Newborn, run by University of Oxford 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 2 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: status not confirmed, as of the sponsor's last update on 21 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Hartley, PhD (+44 1865 234537, caroline.hartley@paediatrics.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate following drug administration (time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.). The study lists 6 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 21 Dec 2023.