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Investigating Changes in Vital Signs in Neonates

NCT ID: NCT06032494

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-20

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Infant Newborn

Keywords

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preterm respiration oxygen saturation heart rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

• Known chromosomal abnormality or life-threatening congenital abnormality
Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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John Radcliffe Hospital

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Caroline Hartley, PhD

Role: CONTACT

Phone: +44 1865 234537

Email: [email protected]

Facility Contacts

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Caroline Hartley, PhD

Role: primary

Other Identifiers

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PID16761

Identifier Type: -

Identifier Source: org_study_id