search
Back to results

CDH - Optimisation of Neonatal Ventilation (CDH-ONV)

Primary Purpose

Congenital Diaphragmatic Hernia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Measurement of PTPdi
TTV at 4ml/kg
TTV at 5ml/kg
TTV at 6ml/kg
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Diaphragmatic Hernia

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • neuromuscular blockade contraindications to NG/OG tube insertion

Sites / Locations

  • King's College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

4, 5, 6ml/kg targetted tidal volume

4, 6, 5ml/kg targetted tidal volume

5, 4, 6ml/kg targetted tidal volume

5, 6, 4ml/kg targetted tidal volume

6, 5, 4ml/kg targetted tidal volume

6, 4, 5ml/kg targetted tidal volume

Arm Description

Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi

Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi

Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi

Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi

Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi

Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2016
Last Updated
August 28, 2018
Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT02849054
Brief Title
CDH - Optimisation of Neonatal Ventilation
Acronym
CDH-ONV
Official Title
Optimisation of Neonatal Ventilation: Congenital Diaphragmatic Hernia - Determining the Appropriate Level of Volume Guarantee
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4, 5, 6ml/kg targetted tidal volume
Arm Type
Experimental
Arm Description
Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi
Arm Title
4, 6, 5ml/kg targetted tidal volume
Arm Type
Experimental
Arm Description
Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi
Arm Title
5, 4, 6ml/kg targetted tidal volume
Arm Type
Experimental
Arm Description
Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi
Arm Title
5, 6, 4ml/kg targetted tidal volume
Arm Type
Experimental
Arm Description
Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi
Arm Title
6, 5, 4ml/kg targetted tidal volume
Arm Type
Experimental
Arm Description
Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi
Arm Title
6, 4, 5ml/kg targetted tidal volume
Arm Type
Experimental
Arm Description
Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi
Intervention Type
Device
Intervention Name(s)
Measurement of PTPdi
Intervention Description
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
Intervention Type
Device
Intervention Name(s)
TTV at 4ml/kg
Intervention Description
Provision of targetted tidal volume of 4ml/kg
Intervention Type
Device
Intervention Name(s)
TTV at 5ml/kg
Intervention Description
Provision of targetted tidal volume of 5ml/kg
Intervention Type
Device
Intervention Name(s)
TTV at 6ml/kg
Intervention Description
Provision of targetted tidal volume of 6ml/kg
Primary Outcome Measure Information:
Title
Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume
Description
PTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi.
Time Frame
3 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Congenital diaphragmatic hernia - post-operative Mechanically ventilated Born at >34/40 Exclusion Criteria: neuromuscular blockade contraindications to NG/OG tube insertion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Hunt, MA, MBBS
Phone
00442032999000
Ext
38492
Email
katie.a.hunt@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Greenough, MD, MBBS
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE59RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Hunt, MA, MBBS
Phone
00442032999000
Ext
38492
Email
katie.a.hunt@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

CDH - Optimisation of Neonatal Ventilation

We'll reach out to this number within 24 hrs