Investigating Changes in Vital Signs in Neonates (Neo-vital)

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.

Study Overview

• Status: Recruiting
• Conditions: Infant; Newborn

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Caroline Hartley, PhD; Phone Number: +44 1865 234537; Email: caroline.hartley@paediatrics.ox.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX14 3XL
    • Recruiting
    • John Radcliffe Hospital
    • Contact: Caroline Hartley, PhD; Phone Number: +44 1865 234537; Email: caroline.hartley@paediatrics.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: preterm; heart rate; oxygen saturation; respiration
• Other Study ID Numbers: PID16761

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No