Clinical trial NCT06032494: Investigating Changes in Vital Signs in Neonates
Official title: Neo-vital: Investigating Changes in Vital Signs in Neonates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant
Newborn
Keywords: preterm
respiration
oxygen saturation
heart rate
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 200
Sex: ALL
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in heart rate following drug administration
timeFrame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
measure: Change in oxygen saturation following drug administration
timeFrame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
measure: Change in respiratory rate following drug administration
timeFrame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
measure: Change in heart rate following procedures
timeFrame: 1 day after procedure, compared with baseline of 1 day before procedure.
measure: Change in oxygen saturation following procedures
timeFrame: 1 day after procedure, compared with baseline of 1 day before procedure.
measure: Change in respiratory rate following procedures
timeFrame: 1 day after procedure, compared with baseline of 1 day before procedure.
Secondary outcomes:
measure: Models of drug response
timeFrame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
measure: Models of procedure response
timeFrame: 1 day after procedure, compared with baseline of 1 day before procedure.
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
References: