CDH - Optimisation of Neonatal Ventilation (CDH-ONV)

King's College London

Status: Unknown

Conditions: Congenital Diaphragmatic Hernia

Treatments: Device: TTV at 5ml/kg; Device: TTV at 6ml/kg; Device: Measurement of PTPdi; Device: TTV at 4ml/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02849054

KCH16-080

Details and patient eligibility

About

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

Enrollment: 18 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

4, 5, 6ml/kg targetted tidal volume

Experimental group

Description:

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

Treatment:

Device: Measurement of PTPdi

Device: TTV at 6ml/kg

Device: TTV at 4ml/kg

Device: TTV at 5ml/kg

4, 6, 5ml/kg targetted tidal volume

Experimental group

Description:

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

Treatment:

Device: Measurement of PTPdi

Device: TTV at 6ml/kg

Device: TTV at 4ml/kg

Device: TTV at 5ml/kg

5, 4, 6ml/kg targetted tidal volume

Experimental group

Description:

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

Treatment:

Device: Measurement of PTPdi

Device: TTV at 6ml/kg

Device: TTV at 4ml/kg

Device: TTV at 5ml/kg

5, 6, 4ml/kg targetted tidal volume

Experimental group

Description:

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

Treatment:

Device: Measurement of PTPdi

Device: TTV at 6ml/kg

Device: TTV at 4ml/kg

Device: TTV at 5ml/kg

6, 5, 4ml/kg targetted tidal volume

Experimental group

Description:

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

Treatment:

Device: Measurement of PTPdi

Device: TTV at 6ml/kg

Device: TTV at 4ml/kg

Device: TTV at 5ml/kg

6, 4, 5ml/kg targetted tidal volume

Experimental group

Description:

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

Treatment:

Device: Measurement of PTPdi

Device: TTV at 6ml/kg

Device: TTV at 4ml/kg

Device: TTV at 5ml/kg