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NCT02849054 Clinical Trial

CDH - Optimisation of Neonatal Ventilation

Congenital Diaphragmatic Hernia Clinical Trial

— CDH-ONV  

Official title:
Optimisation of Neonatal Ventilation: Congenital Diaphragmatic Hernia - Determining the Appropriate Level of Volume Guarantee

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02849054
Other study ID # KCH16-080
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2021

Study information
Verified date August 2018
Source King's College London
Contact Katie Hunt, MA, MBBS
Phone 00442032999000
Email katie.a.hunt@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- Congenital diaphragmatic hernia - post-operative Mechanically ventilated Born at >34/40

Exclusion Criteria:

- neuromuscular blockade contraindications to NG/OG tube insertion

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Measurement of PTPdi
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
• TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg
• TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg
• TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg

Locations
Country Name City State
United Kingdom King's College Hospital London

Sponsors (2)
Lead Sponsor Collaborator
King's College London King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume PTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi. 3 hours
See also
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Recruiting NCT04583644 - Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) N/A
Completed NCT03314233 - Delayed Cord Clamping for Congenital Diaphragmatic Hernia N/A
Recruiting NCT04114578 - Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
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Recruiting NCT02986087 - Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia N/A
Recruiting NCT03674372 - Fetoscopic Endoluminal Tracheal Occlusion N/A
Active, not recruiting NCT05839340 - Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias N/A
Enrolling by invitation NCT05962346 - Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia N/A
Withdrawn NCT04186039 - Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations N/A
Unknown status NCT01302977 - Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial Phase 2
Recruiting NCT03179371 - Proteomic Profiling for Congenital Diaphragmatic Hernia
Recruiting NCT03138863 - Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO) N/A
Active, not recruiting NCT04484441 - Maternal-fetal Immune Responses to Fetal Surgery