NCT06037629

Brief Summary

The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

March 29, 2023

Last Update Submit

September 7, 2023

Conditions

Acute PainPain, ProceduralAgitationDiscomfort

Outcome Measures

Primary Outcomes (12)

  • Pain Score Before Procedure

    Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.

    1 minute recording before procedure

  • Audiovisual signal Before Procedure

    Bedside recording using camera and microphone.

    1 minute starting before procedure

  • Physiologic Signal Before Procedure: Heart Rate

    Heart rate captured by bedside ECG monitor

    1 minute starting before procedure

  • Physiologic Signal Before Procedure: Blood Oxygen Saturation

    Blood oxygen saturation captured by bedside oximetry monitor

    1 minute starting before procedure

  • Pain Score During Procedure

    Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.

    1 minute recording during procedure

  • Audiovisual Signal During Procedure

    Bedside recording using camera and microphone

    1 minute during procedure

  • Physiologic Signal During Procedure: Heart Rate

    Heart rate captured by bedside ECG monitor

    1 minute during procedure

  • Physiologic Signal During Procedure: Blood Oxygen Saturation

    Blood oxygen saturation captured by bedside oximetry monitor

    1 minute during procedure

  • Pain Score After Procedure

    Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.

    1 minute recording immediately after procedure

  • Audiovisual Signal After Procedure

    Bedside recording using camera and microphone

    1 minute immediately after procedure

  • Physiologic Signal After Procedure: Heart Rate

    Heart rate captured by bedside ECG monitor

    1 minute immediately after procedure

  • Physiologic Signal After Procedure: Blood Oxygen Saturation

    Blood oxygen saturation captured by bedside oximetry monitor

    1 minute immediately after procedure

Study Arms (1)

Preterm neonates in intensive care

Preterm neonates born \<36 completed weeks of gestation with postmenstrual age \<36 weeks

Eligibility Criteria

AgeUp to 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm neonates hospitalised in the Royal Victoria Infirmary Neonatal Intensive Care Unit

You may qualify if:

  • Preterm Infants born \<36 completed weeks of gestation
  • Medically stable
  • Written informed consent from parents

You may not qualify if:

  • Infants with significant brain, spine, or congenital abnormality
  • Parents unwilling to provide consent
  • Infants with postmenstrual age \>36 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acute PainPain, ProceduralPsychomotor Agitation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesiasNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2023

First Posted

September 14, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)