NCT05278247

Brief Summary

Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2). Near infrared spectroscopy (NIRS) is a technique available to non-invasively and safely monitor the tissue oxygenation status (StO2), which can be beneficial or live saving for this fragile patient population. Unfortunately, traditional NIRS devices show a broad variability when applied to the abdomen (Bailey \& Mally 2016). The novel device is designed especially for application of NIRS on the abdomen of preterm infants.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Feb 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

February 22, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
3.9 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

February 22, 2022

Last Update Submit

November 24, 2025

Conditions

NEC

Keywords

abdominal NIRS for oxygen saturation

Outcome Measures

Primary Outcomes (1)

  • Performance of the CTOM system

    We intend to investigate sensor handling on preterm infants and record the signal variability and reproducibility. A measurement signal serves to analyse reproducibility, signal quality and different signal analysis methods. Abdominal oxygen tissue saturation will be calculated. The aStO2 values will be calculated with and without considering the presence of additional absorbers besides haemoglobin. The datasets to be analysed include three measurement series per subject from a total of at least 50 subjects. The planned analyses consist of descriptive statistics and time series analysis.

    3 days

Secondary Outcomes (1)

  • Occurrence of adverse events is measured

    3 days

Study Arms (1)

single arm for all subjects

EXPERIMENTAL

all subjects receive the same diagnostic measurement

Diagnostic Test: NIRS

Interventions

NIRSDIAGNOSTIC_TEST

Performance of a NIRS to monitor abdominal tissue oxygen saturation in preterm infants

single arm for all subjects

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants with Gestational age less than 35 0/7 weeks
  • Signed Informed consent of the legal representative(s) is received after being informed. The consent form is signed by one legal representative, which is likely to be either the mother or the father. Only married fathers or those listed on the birth certificate are considered under UK regulations. In the case of non-married father, the mother must provide consent.
  • Clinically stable condition. The clinical stability is to be reconfirmed before the start and checked during the measurement.

You may not qualify if:

  • Injured, hypersensitive or bruised skin present on the abdomen,
  • Any medical care equipment, e.g. patches, dressing, umbilical arterial or venous catheter, blood supply, etc., prohibiting correct placement of the sensors,
  • Severe Congenital malformations,
  • Clinical abdominal concerns
  • Severe metabolic disorders,
  • Early onset sepsis,
  • Inability of legal representatives to understand the purpose of the clinical trial due to language barriers such as the insufficient ability to understand the spoken or written language,
  • The treatment of newborn jaundice with light during measurement time phase 1 and 2,
  • Previous enrolment into the current study,
  • Family members, employees and other dependent persons of the investigator,
  • Participation in another study with investigational drug/device within the preceding days and during the present study which may influence abdominal oxygen saturation.
  • Known silicone allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Elaine Chapman

    lead NHS R&D contact

    STUDY CHAIR

Central Study Contacts

Jane Berrington, Dr.

CONTACT

+44 (0) 191 282janet.berrington1@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: confirmatory, open, single-arm, mono-centric
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 14, 2022

Study Start

February 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share