NCT02849054

Brief Summary

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

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
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

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

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

5.5 years

First QC Date

July 18, 2016

Last Update Submit

August 28, 2018

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

4, 5, 6ml/kg targetted tidal volume

EXPERIMENTAL

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

Device: Measurement of PTPdiDevice: TTV at 4ml/kgDevice: TTV at 5ml/kgDevice: TTV at 6ml/kg

4, 6, 5ml/kg targetted tidal volume

EXPERIMENTAL

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

Device: Measurement of PTPdiDevice: TTV at 4ml/kgDevice: TTV at 5ml/kgDevice: TTV at 6ml/kg

5, 4, 6ml/kg targetted tidal volume

EXPERIMENTAL

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

Device: Measurement of PTPdiDevice: TTV at 4ml/kgDevice: TTV at 5ml/kgDevice: TTV at 6ml/kg

5, 6, 4ml/kg targetted tidal volume

EXPERIMENTAL

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

Device: Measurement of PTPdiDevice: TTV at 4ml/kgDevice: TTV at 5ml/kgDevice: TTV at 6ml/kg

6, 5, 4ml/kg targetted tidal volume

EXPERIMENTAL

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

Device: Measurement of PTPdiDevice: TTV at 4ml/kgDevice: TTV at 5ml/kgDevice: TTV at 6ml/kg

6, 4, 5ml/kg targetted tidal volume

EXPERIMENTAL

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

Device: Measurement of PTPdiDevice: TTV at 4ml/kgDevice: TTV at 5ml/kgDevice: TTV at 6ml/kg

Interventions

Measurement of PTPdiDEVICE

Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

4, 5, 6ml/kg targetted tidal volume4, 6, 5ml/kg targetted tidal volume5, 4, 6ml/kg targetted tidal volume5, 6, 4ml/kg targetted tidal volume6, 4, 5ml/kg targetted tidal volume6, 5, 4ml/kg targetted tidal volume
TTV at 4ml/kgDEVICE

Provision of targetted tidal volume of 4ml/kg

4, 5, 6ml/kg targetted tidal volume4, 6, 5ml/kg targetted tidal volume5, 4, 6ml/kg targetted tidal volume5, 6, 4ml/kg targetted tidal volume6, 4, 5ml/kg targetted tidal volume6, 5, 4ml/kg targetted tidal volume
TTV at 5ml/kgDEVICE

Provision of targetted tidal volume of 5ml/kg

4, 5, 6ml/kg targetted tidal volume4, 6, 5ml/kg targetted tidal volume5, 4, 6ml/kg targetted tidal volume5, 6, 4ml/kg targetted tidal volume6, 4, 5ml/kg targetted tidal volume6, 5, 4ml/kg targetted tidal volume
TTV at 6ml/kgDEVICE

Provision of targetted tidal volume of 6ml/kg

4, 5, 6ml/kg targetted tidal volume4, 6, 5ml/kg targetted tidal volume5, 4, 6ml/kg targetted tidal volume5, 6, 4ml/kg targetted tidal volume6, 4, 5ml/kg targetted tidal volume6, 5, 4ml/kg targetted tidal volume

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • neuromuscular blockade contraindications to NG/OG tube insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE59RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Greenough, MD, MBBS

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Hunt, MA, MBBS

CONTACT

00442032999000katie.a.hunt@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 29, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

GB(1)