Investigating Changes in Vital Signs in Neonates

Newborn Clinical Trial

— Neo-vital  

Official title:

Neo-vital: Investigating Changes in Vital Signs in Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032494
• Other study ID #: PID16761
• Status: Recruiting
• Start date: September 20, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2023
• Source: University of Oxford
• Contact: Caroline Hartley, PhD
• Phone: +44 1865 234537
• Email: caroline.hartley[@]paediatrics.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 42 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Infants will be ineligible if the following exclusion criteria applies:

• Known chromosomal abnormality or life-threatening congenital abnormality

Related Conditions & MeSH terms

• Infant
• Newborn

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day after drug administration, compared with baseline of 1 day before drug administration.
Primary	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	1 day after drug administration, compared with baseline of 1 day before drug administration.
Primary	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	1 day after drug administration, compared with baseline of 1 day before drug administration.
Primary	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.	1 day after procedure, compared with baseline of 1 day before procedure.
Primary	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.	1 day after procedure, compared with baseline of 1 day before procedure.
Primary	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.	1 day after procedure, compared with baseline of 1 day before procedure.
Secondary	Models of drug response	Prediction of drug regimen requirements in individual infants from respiratory rate.	1 day after drug administration, compared with baseline of 1 day before drug administration.
Secondary	Models of procedure response	Prediction of procedure outcome in individual infants (e.g. extubation success) from respiratory rate	1 day after procedure, compared with baseline of 1 day before procedure.