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

University of Oxford

Status: Enrolling

Conditions: Newborn; Infant

Study type: Observational

Funder types: Other

Identifiers

NCT06032494

PID16761

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 42 weeks old

Volunteers: No Healthy Volunteers

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