## Protocol Section
### Identification Module
**NCT ID:** NCT06416956

**Acronym:** Baby-CINO

**Brief Title:** Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

**Official Title:** Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

#### Organization Study ID Info
**ID:** PID17161
#### Organization
**Class:** OTHER
**Full Name:** University of Oxford
#### Secondary ID Infos
**Domain:** Research Ethics Committee
**ID:** 23/SC/0397
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-11

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Oxford

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. The study will assess premature babies receiving caffeine treatment as part of their clinical care. Brain activity will be recorded just before caffeine dose is changed and again two days afterwards. Breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards.

### Conditions Module

**Conditions:**

- Infant,Premature

- Caffeine

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Preterm infants receiving caffeine (prescribed clinically) will be studied

**Intervention Names:**

- Drug: Caffeine

**Label:** Preterm infant

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Preterm infant

**Description:** We will record infant\&#39;s brain activity and vital signs when caffeine dose is changed or caffeine treatment is stopped. The decision to change dose/stop treatment will be made by the clinical team as part of routine care. No changes in caffeine treatment will be carried out solely for research purposes.

**Name:** Caffeine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change in respiratory dynamics between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later

**Measure:** Respiration

**Time Frame:** From baseline to two days later

**Description:** Change in EEG activity between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later

**Measure:** Brain activity

**Time Frame:** From baseline to two days later

#### Secondary Outcomes

**Description:** Change in heart rate between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later

**Measure:** Heart rate

**Time Frame:** From baseline to two days later

**Description:** Change in oxygen saturation between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later

**Measure:** Oxygen saturation

**Time Frame:** From baseline to two days later

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Born to a mother aged 16 or over
* Admitted to the Newborn Care Unit, John Radcliffe Hospital
* Born prematurely (before 37 weeks' gestation)
* Parent given informed written consent
* Receiving caffeine citrate

Exclusion Criteria:

* Known chromosomal abnormality or life-threatening congenital abnormality
* Severe hypoxic insult at birth
* Intraventricular haemorrhage grade III or IV or other severe neurological pathology

**Maximum Age:** 37 Weeks

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** All participants will be inpatients on the Newborn Care Unit and born prematurely (before 37 weeks gestation)

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** caroline.hartley@paediatrics.ox.ac.uk

**Name:** Caroline Hartley

**Phone:** +44 1865 234537

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Oxford

**Contacts:**

***Contact 1:***

- **Email:** caroline.hartley@paediatrics.ox.ac.uk

- **Name:** Caroline Hartley

- **Phone:** +44 1865 234537

- **Role:** CONTACT

***Contact 2:***

- **Name:** Caroline Hartley, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United Kingdom

**Facility:** Newborn Care Unit, John Radcliffe Hospital

**State:** Oxfordshire

**Status:** RECRUITING

**Zip:** OX3 9DU

#### Overall Officials

**Official 1:**

**Affiliation:** University of Oxford

**Name:** Caroline Hartley

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Premature

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

### Intervention Browse Module - Ancestors

- ID: D000000697

- Term: Central Nervous System Stimulants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000058915

- Term: Purinergic P1 Receptor Antagonists

- ID: D000058914

- Term: Purinergic Antagonists

- ID: D000058905

- Term: Purinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M5373

- Name: Caffeine

- Relevance: HIGH

- As Found: 800

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: T370

- Name: Caffeine

- Relevance: HIGH

- As Found: 800

### Intervention Browse Module - Meshes

- ID: D000002110

- Term: Caffeine

### Misc Info Module

- Version Holder: 2024-05-31
