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CDH - Optimisation of Neonatal Ventilation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02849054
Acronym
CDH-ONV
Enrollment
18
Registered
2016-07-29
Start date
2016-06-30
Completion date
2021-12-31
Last updated
2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Diaphragmatic Hernia

Brief summary

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

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

Sponsors

King's College Hospital NHS Trust
CollaboratorOTHER
King's College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* neuromuscular blockade contraindications to NG/OG tube insertion

Design outcomes

Primary

MeasureTime frameDescription
Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume3 hoursPTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi.

Countries

United Kingdom

Contacts

Primary ContactKatie Hunt, MA, MBBS
katie.a.hunt@kcl.ac.uk00442032999000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026