NCT02967549

Brief Summary

This study aims to assess whether neurally adjusted ventilatory assist or proportional assist ventilation is more effective in infants born prematurely with evolving or established bronchopulmonary dysplasia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 22, 2021

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

November 15, 2016

Last Update Submit

September 15, 2021

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

  • Oxygenation index

    Oxygenation index at the end of each period of ventilation

    2 hours

Study Arms (2)

NAVA then PAV

EXPERIMENTAL

Infants randomised to NAVA then PAV

Device: NAVADevice: PAV

PAV then NAVA

EXPERIMENTAL

Infants randomised to PAV then NAVA

Device: NAVADevice: PAV

Interventions

NAVADEVICE

NAVA delivered by the Servo-n ventilator (Maquet)

Also known as: neurally adjusted ventilatory assist
NAVA then PAVPAV then NAVA
PAVDEVICE

PAV delivered by the Stephanie ventilator (Stephan)

Also known as: Proportional Assist Ventilation
NAVA then PAVPAV then NAVA

Eligibility Criteria

Age1 Week - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Born at less than 32 weeks gestation
  • ventilated at or beyond one week of life

You may not qualify if:

  • major congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

  • Hunt KA, Dassios T, Greenough A. Proportional assist ventilation (PAV) versus neurally adjusted ventilator assist (NAVA): effect on oxygenation in infants with evolving or established bronchopulmonary dysplasia. Eur J Pediatr. 2020 Jun;179(6):901-908. doi: 10.1007/s00431-020-03584-w. Epub 2020 Jan 25.

    PMID: 31980954BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Anne Greenough, MD, FRCPCH

    King's College London

    STUDY DIRECTOR

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

November 15, 2016

First Posted

November 18, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 22, 2021

Record last verified: 2018-03

Locations

GB(1)