Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
NAN-C
1 other identifier
interventional
18
1 country
2
Brief Summary
Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Our dual-centre randomised cross-over trial aims to investigate the efficacy of NIV-NAVA compared to ACV for supporting neonates with CDH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedStudy Start
First participant enrolled
May 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJune 1, 2023
May 1, 2023
1 year
April 7, 2023
May 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Oxygenation Index (OI)
Oxygenation Index is calculated as MAP x FIO2 x PaO2/100. MAP is the mean airway pressure. FIO2 represents the concentration of inspired oxygen and PAO2 is the partial pressure of oxygen. The OI is a reliable indicator of lung function, previous research has shown its use in the prognostication of neonates with CDH.
Infants will receive each mode of ventilation for four hours. OI will be recorded every 5-minutes for the final 30-minutes of each ventilation period. The OI will be averaged over the 30-minute time frame. This average OI will then be compared.
Secondary Outcomes (1)
Respiratory Severity Score (RSS)
RSS will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
Other Outcomes (5)
Mean Airway Pressure (MAP)
MAP will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
Fraction of Inspired Oxygen (FIO2)
FIO2 will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
Peak Inspiratory Pressure (PIP)
PIP will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
- +2 more other outcomes
Study Arms (2)
Neurally Adjusted Ventilatory Assist
EXPERIMENTALInfants will first be ventilated with NAVA for four hours. Following this, they will undergo a 20-minute stabilisation period prior to ventilating with assist control ventilation (ACV).
Assist Control Ventilation (ACV)
EXPERIMENTALInfants will first be ventilated with ACV for four hours. Following this, they will undergo a 20-minute stabilisation period prior to ventilating with non-invasive neurally adjusted ventilatory assist.
Interventions
NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen, to which proportion is set by the clinician as the NAVA level.
ACV delivers fixed oxygen pressure set by the clinician at the start of each inspiratory breath.
Eligibility Criteria
You may qualify if:
- Infants born with congenital diaphragmatic hernia more than 34-weeks gestation
You may not qualify if:
- Receiving Nitric Oxide
- Requiring an FIO2 more than 80% to maintain SpO2: 85-95%.
- Severe chromosomal abnormality
- Severe cardiac anomalies requiring corrective surgery
- Renal anomalies
- Skeletal deformities suspected to impede thoracic or lung development
- Severe central nervous system anomalies suspected to impede diaphragmatic signalling
- Use of neuromuscular blocking agents
- Contraindication to nasogastric tube insertion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kings College Hospital
London, United Kingdom
St. George's University Hospital
London, United Kingdom
Related Publications (1)
Poole G, Harris C, Shetty S, Dassios T, Jenkinson A, Greenough A. Study protocol for a randomised cross-over trial of Neurally adjusted ventilatory Assist for Neonates with Congenital diaphragmatic hernias: the NAN-C study. Trials. 2024 Jan 20;25(1):72. doi: 10.1186/s13063-023-07874-0.
PMID: 38245741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Due to practical limitations, the trial will be open label.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neonatology and Clinical Respiratory Physiology
Study Record Dates
First Submitted
April 7, 2023
First Posted
May 3, 2023
Study Start
May 26, 2023
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
June 1, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- It is our intent that the NAN-C protocol will be published, following SPIRIT guidelines, following the start of the trial. At present, there are no plans to grant public access to the full protocol, participant-level data set or statistical code. For 6-months following publication of the final study results, investigators will be granted priority for secondary data analyses. Following this period, requests for de-identified data will be considered. Requests for data presented in the final paper should be submitted via email to Professor Anne Greenough.
- Access Criteria
- Requests for data presented in the final paper should be submitted via email to Professor Anne Greenough.
Requests for individual participant data will be reviewed by the principal investigator. On request, data will be made available to other researchers 6-months following trial cessation. Parents will be consented to share their child's data for research purposes. All data will be anonymised on entry into the trial so no individual data point will be recognisable.