NCT04936477

Brief Summary

To non-invasively estimate the alveolar surface area of the lungs of prematurely born infants by taking measurements of oxygen and carbon dioxide and utilizing functional morphometry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 29, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

March 17, 2023

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

June 15, 2021

Last Update Submit

March 16, 2023

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

  • Calculation of the alveolar surface area in prematurely born infants using validated functional morphometry

    One year

Study Arms (1)

Assessment of alveolar surface area by functional morphometry

EXPERIMENTAL

Non-invasive measurements of V/Q

Other: Calculation of ventilation-perfusion ratio

Interventions

Calculation of ventilation-perfusion ratioOTHER

Three to five paired measurements of fraction of inspired oxygen and peripheral oxygen saturations. Insertion of mainstream capnograph with combined pressure and flow sensor to perform end-tidal capnography measurement. Echocardiogram to assess intra-cardiac shunting.

Assessment of alveolar surface area by functional morphometry

Eligibility Criteria

Age22 Weeks - 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Congenital or chromosomal anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Anne Greenough

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 23, 2021

Study Start

September 29, 2020

Primary Completion

June 30, 2022

Study Completion

January 30, 2023

Last Updated

March 17, 2023

Record last verified: 2022-08

Locations

GB(1)