UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055670 |
|---|---|
| Receipt number | R000061031 |
| Scientific Title | A Randomized Controlled Trial Comparing Neurally Adjusted Ventilatory Assist (NAVA) with Synchronized Intermittent Mandatory Ventilation (SIMV+PS) in Preterm Infants Born at 26-31 Weeks of Gestation with Respiratory Distress Syndrome (RDS) |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/10/02 17:37:47 |
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Basic information
Public title
A Randomized Controlled Trial Comparing Neurally Adjusted Ventilatory Assist (NAVA) with Synchronized Intermittent Mandatory Ventilation (SIMV+PS) in Preterm Infants with Respiratory Distress Syndrome (RDS)
Acronym
A RCT comparing NAVA with SIMV+PS in preterm infants with RDS
Scientific Title
A Randomized Controlled Trial Comparing Neurally Adjusted Ventilatory Assist (NAVA) with Synchronized Intermittent Mandatory Ventilation (SIMV+PS) in Preterm Infants Born at 26-31 Weeks of Gestation with Respiratory Distress Syndrome (RDS)
Scientific Title:Acronym
A RCT comparing NAVA with SIMV+PS in preterm born at 26-31 weeks of GA with RDS
Region
| Japan |
Condition
Condition
A neonate born between 26 weeks 0 days and 31 weeks 6 days of gestation, admitted to our neonatal intensive care unit from October 1, 2024, to September 30, 2025, with a diagnosis of respiratory distress syndrome
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing which respiratory management strategy leads to earlier extubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration of endotracheal intubation
Key secondary outcomes
hospitalization period in NICU,hospitalization period, weight gain rate, age at achieving enteral nutrition (WQ100) and age at achieving full enteral nutrition.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
SIMV and PS:Initial Settings,Weaning,and Extubation Criteria are the same as standard clinical practice.Initial Settings:Peak Inspiratory Pressure(PIP):20cmH2O,Positive End-Expiratory Pressure(PEEP):5cmH2O,Respiratory Rate:40breaths per min,Inspiratory Time(Ti):0.35seconds and Pressure Support(PS):12cmH2O.Volume Guarantee(VG) Mode:VG mode will not be used immediately after birth. It will be added after confirming the absence of atelectasis, pneumothorax, malposition of the endotracheal tube, or decreased lung field transparency on chest X-ray.When using VG mode,tidal volume will be set to 4-6ml based on body weight.Weaning:The PIP will be reduced while maintaining a tidal volume of 4-6ml based on body weight.PEEP will be reduced to 4-5cmH2O.Respiratory rate will be decreased by 10breaths/min, while maintaining PaCO2 at 40-65mmHg and pH greater than or equal to 7.25, confirmed by blood gas analysis.PS will be adjusted to 30-50% of(PIP-PEEP) and gradually reduced to below30%.Extubation Criteria:Extubation will be performed when the following criteria are met:FiO2 less than or equal to 0.4,Mean Airway Pressure (MAP) less than or equal to 8cmH2O,Respiratory rate of 16-20breaths per min,PSless than or equal to 30% of (PIP-PEEP) and Blood gas analysis confirming pH greater than or equal to 7.25and PaCO2 less than or equal to 60mmHg.Post Extubation Respiratory Management:NIPPV(Non Invasive Positive Pressure Ventilation)will be used. Settings:Peak Inspiratory Pressure (PIP):16cmH2O or PIP which is added 2 to pre extubated PIP, Positive End Expiratory Pressure(PEEP):6cmH2O, Inspiratory Time(Ti):0.5-0.6seconds,Respiratory Rate:25-40breaths per min,FiO2:less than or equal to 0.4 and One hour after extubation and for the following three days.
Interventions/Control_2
NAVA:Initial Settings, Weaning, and Extubation Criteria are the same as standard clinical practice. Initial Settings:NAVA Level:2cmH2O,Positive End-Expiratory Pressure (PEEP):7cmH2O, Apnea Time:2seconds, Pressure Level Above PEEP in Backup:10 cmH2O,Backup Rate: 40breaths per min, Inspiratory Time (Ti): 0.4seconds and safety limit for PIP:25cmH2O.Weaning:The peak diaphragm electrical activity(Edi peak) will be maintained at 5-15while decreasing NAVA level by 0.2-0.3per day.PEEP will be reduced while maintaining the minimum diaphragm electrical activity (Edi mini) at less than or equal to 1.The apnea time will be extended to achieve a backup percentage of approximately 10%. Extubation Criteria: Extubation will be performed when the following criteria are met:FiO2 0.4, PIP less than or equal to 16cmH2O, NAVA Level less than or equal to 1.0 and Apnea Time greater than or equal to 4seconds.After modification, if Edi peak is maintained at 5-15and Edi mini less than or equal to 1, the NAVA mode will be switched to SIMV and PS while retaining the Edi catheter. Settings during the switch will include: FiO2 less than or equal to 0.4, PIP 16cmH2O, NAVA Level 1.0 and Apnea Time greater than or equal to 4seconds. After modification, if Edi peak is maintained at 5-15and Edi mini less than or equal to 1, the NAVA mode will be switched to SIMV and PS while retaining the Edi catheter. Settings during the switch will include: FiO2 less than or equal to 0.4, MAP less than or equal to 8cmH2O, respiratory rate of 16-20breaths per min, and PS less than or equal to 30% of(PIP-PEEP). Blood gas analysis will confirm pH greater than or equal to 7.25and PaCO2 less than or equal to 60mmHg before extubation. Post extubation Respiratory Management: NIPPV will be used.The NIPPV management after NAVA is the same as the management after SIMV and PS.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 1 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Preterm infants diagnosed with respiratory distress syndrome between 26 weeks and 0 days and 31 weeks and 6 days of gestation.
Neonates diagnosed with respiratory distress syndrome.
The diagnosis is made if any of the following criteria are met:
Microbubble test (diagnostic criteria of Chida):
Fewer than 5 microbubbles/mm2 in the amniotic fluid, or
Fewer than 10 microbubbles/mm2 in the gastric aspirate.
Chest X-ray (Bomsel classification):
The presence of any of the following findings: reticulogranular pattern, ground-glass opacity, bronchial air column, or white-out appearance.
Symptoms:
The presence of tachypnea, nasal flaring, grunting, retractions, or cyanosis.
Infants born between Octorber 1, 2024, and September 30, 2025.
Infants for parental (proxy) consent for research participation was obtained within 23 hours post-birth.
Includes both neonates born within this hospital and those born at other hospitals.
Key exclusion criteria
Cases of tracheomalacia, bronchomalacia, and pulmonary hypoplasia.
Cases of congenital gastrointestinal diseases such as esophageal atresia and small bowel atresia.
Cases of chromosomal abnormalities, neuromuscular diseases, and congenital heart diseases.
Cases where the umbilical artery blood pH at birth or the initial blood gas pH of the patient was less than 7.0.
Cases where it was not possible to explain the randomized controlled trial within 23 hours of birth, and the assigned respiratory support could not be used within 24 hours of birth.
Cases who are deemed inappropriate by the physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Kurimoto |
Organization
Kagoshima City Hospital
Division name
neonatology
Zip code
890-8760
Address
37-1 Uearatacho, Kagoshima
TEL
81-99-230-7000
maron.n.tomo.o@gmail.com
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Kurimoto |
Organization
Kagoshima City Hospital
Division name
neonatology
Zip code
890-8760
Address
37-1 Uearatacho, Kagoshima
TEL
81-99-230-7000
Homepage URL
https://www.kch.kagoshima.jp/bumon/yakuzai_chiken/meibo/
maron.n.tomo.o@gmail.com
Sponsor or person
Institute
Kagoshima University
Kagoshima City Hospital Neonatology
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Perinatal and Neonatal Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima City Hospital
Address
Kagoshima City Hospital
Tel
81-99-230-7000
maron.n.tomo.o@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Kagoshima City Hospital (Kagoshima)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061031
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