CClinicalTrials.gg
Status unknownNCT02849054CDH-ONVUpdated Aug 29, 2018

CDH - Optimisation of Neonatal Ventilation

An interventional study of Measurement of PTPdi and TTV at 4ml/kg in Congenital Diaphragmatic Hernia, sponsored by King's College London. Status unknown at 1 site in United Kingdom. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by King's College London · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
Up to 6 Months
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Hernias, Diaphragmatic, Congenital

93 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.

This study's planned enrollment of 18 is below the median of 28 across 64 interventional studies indexed under Hernias, Diaphragmatic, Congenital.

Browse Hernias, Diaphragmatic, Congenital studies →

Lead sponsor

King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • neuromuscular blockade contraindications to NG/OG tube insertion
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • 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 · Device: TTV at 4ml/kg · Device: TTV at 5ml/kg · Device: TTV at 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 · Device: TTV at 4ml/kg · Device: TTV at 5ml/kg · Device: TTV at 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 · Device: TTV at 4ml/kg · Device: TTV at 5ml/kg · Device: TTV at 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 · Device: TTV at 4ml/kg · Device: TTV at 5ml/kg · Device: TTV at 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 · Device: TTV at 4ml/kg · Device: TTV at 5ml/kg · Device: TTV at 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 · Device: TTV at 4ml/kg · Device: TTV at 5ml/kg · Device: TTV at 6ml/kg

Interventions

  • DeviceMeasurement of PTPdi

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

  • DeviceTTV at 4ml/kg

    Provision of targetted tidal volume of 4ml/kg

  • DeviceTTV at 5ml/kg

    Provision of targetted tidal volume of 5ml/kg

  • DeviceTTV at 6ml/kg

    Provision of targetted tidal volume of 6ml/kg

06

What researchers measure

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.

    Time frame: 3 hours

07

Study locations

1 of 1 sites recruiting
  • King's College Hospital
    London, SE59RS, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02849054
Lead sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
Responsible party
Sponsor
First posted
Jul 29, 2016
Start date
Jun 2016
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Aug 29, 2018

Study contacts

Katie Hunt, MA, MBBS
Contact
katie.a.hunt@kcl.ac.uk
00442032999000 ext. 38492
Anne Greenough, MD, MBBS
principal investigator · King's College London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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