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CDH - Optimisation of Neonatal Ventilation (CDH-ONV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02849054
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
King's College Hospital NHS Trust
Information provided by (Responsible Party):
King's College London

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

Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Device: Measurement of PTPdi Device: TTV at 4ml/kg Device: TTV at 5ml/kg Device: TTV at 6ml/kg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimisation of Neonatal Ventilation: Congenital Diaphragmatic Hernia - Determining the Appropriate Level of Volume Guarantee
Study Start Date : June 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: 4, 5, 6ml/kg targetted tidal volume
Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi
Device: Measurement of PTPdi
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg

Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg

Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg

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

Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg

Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg

Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg

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

Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg

Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg

Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg

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

Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg

Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg

Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg

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

Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg

Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg

Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg

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

Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg

Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg

Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg




Primary Outcome Measures :
  1. Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume [ Time Frame: 3 hours ]
    PTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • neuromuscular blockade contraindications to NG/OG tube insertion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849054


Contacts
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Contact: Katie Hunt, MA, MBBS 00442032999000 ext 38492 katie.a.hunt@kcl.ac.uk

Locations
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United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE59RS
Contact: Katie Hunt, MA, MBBS    00442032999000 ext 38492    katie.a.hunt@kcl.ac.uk   
Sponsors and Collaborators
King's College London
King's College Hospital NHS Trust
Investigators
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Principal Investigator: Anne Greenough, MD, MBBS King's College London

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02849054    
Other Study ID Numbers: KCH16-080
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Congenital Abnormalities