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PrematurityNCT03388437

Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation

A study testing NI-NAVA and NIPPV in people with Prematurity and Respiratory Failure, run by King Fahad Armed Forces Hospital at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Non-invasive respiratory support has been emerging in the management of respiratory distress syndrome (RDS) in preterm infants to minimise the risk of lung injury. Intermittent positive pressure ventilation (NIPPV) provides a method of augmenting continuous positive airway pressure (CPAP) by delivering ventilator… Read more about this study

Who is it for?
Ages Up to 2 weeks
What is being tested?
NI-NAVA and NIPPV
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSaudi Arabia
Study dates
1 May 2017to 30 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 2 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Born less than 32 weeks gestation with respiratory distress syndrome (RDS) and requiring endotracheal tube and mechanical ventilation.
  • Less than two weeks old
  • First extubation attempt
  • CRIB score 0-5
  • Written-informed parental consent for the study

Who cannot join

  • Major congenital malformations or respiratory abnormalities
  • Neuromuscular disease
  • phrenic nerve palsy
  • Intraventricular hemorrhage (IVH) grade III or IV
  • Absence of informed consent
  • Out born infants

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • King Fahad Armed Forces Hospital

    Jeddah, 21159

Other trials in Saudi Arabia

About this study

Official title: Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation: A Randomised Control Trial

Non-invasive respiratory support has been emerging in the management of respiratory distress syndrome (RDS) in preterm infants to minimise the risk of lung injury. Intermittent positive pressure ventilation (NIPPV) provides a method of augmenting continuous positive airway pressure (CPAP) by delivering ventilator breaths via nasal prongs.It may increase tidal volume, improve gas exchange and reduce work of breathing. However, NIPPV may associate with patient-ventilator asynchrony that can cause poor tolerance and risk of intubation. It may also in increased risk of pneumothorax and bowel perforation because of increase in intrathoracic pressure.

On the other hand, neurally adjusted ventilatory assist (NAVA) is a newer mode of ventilation, which has the potential to overcome these challenges. It uses the electrical activity of the diaphragm (EAdi) as a signal to synchronise the mechanical ventilatory breaths and deliver an inspiratory pressure based on this electrical activity. Comparing NI-NAVA and NIPPV in preterm infants, has shown that NI-NAVA improved the synchronization between patient and ventilator and decreased diaphragm work of breathing .

Read more

There is lack of data on the use of NI-NAVA in neonates post extubation in the literature. To date, no study has focused on short-term impacts. Therefore, it is important to evaluate the need of additional ventilatory support post extubation of NI-NAVA and NIPPV and also the risk of developing adverse outcomes.

Aim:

The aim is to compare NI-NAVA \& NIPPV in terms of extubation failure in infants< 32 weeks gestation.

Hypothesis:

Investigators hypothesized that infants born prematurely < 32 weeks gestation who extubated to NI-NAVA have a lower risk of extubation failure and need of additional ventilatory support.

Read the detailed description

Study Design: Randomised controlled trial

Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia

Being tested
NI-NAVA, NIPPV
Keywords
Non-invasive Neurally Adjusted Ventilatory Assist NI-NAVA, Nasal Intermittent Positive Pressure Ventilation NIPPV, post extubation
Medical subject headings
Premature Birth, Respiratory Insufficiency, Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NI-NAVADevice

    Enrolled infants will receive Surfactant and loading dose of Caffeine citrate prior to extubation. The criteria for extubation will be as per attending decision.

    The device is used Servo-I ventilator (MAQUET). FiO 2 % is adjusted to maintain oxygen saturation between 90-94% on pulse oximetry. The flow rate is 8-10 L/min. NAVA electrodes will be inserted within nasogastric catheter \& positioned at the level of diaphragm.Vital signs and ventilatory parameters are monitored hourly. Blood gases will be measured before and one hour after extubation

  • NIPPVDevice

    Enrolled infants will receive Surfactant and loading dose of Caffeine citrate prior to extubation. The criteria for extubation will be as per attending decision.

    The device is used Servo-I ventilator (MAQUET). FiO 2 % is adjusted to maintain oxygen saturation between 90-94% on pulse oximetry. The flow rate is 8-10 L/min. NAVA electrodes will be inserted within nasogastric catheter \& positioned at the level of diaphragm.Vital signs and ventilatory parameters are monitored hourly. Blood gases will be measured before and one hour after extubation

Study groups in NCT03388437
Study groupRoleWhat they receive
NI-NAVAExperimentalInitial setting; NAVA level of 2; PEEP of 5-6 cm H 2 O, apnea time 5-10 seconds, target Edi maximum between 10-15 and minimum < 5 for 72 hours post extubation
Receives: Device: NI-NAVA
NIPPVActive comparatorInitial setting; PIP can be increased by 2 cm H 2 O from the pre-extubation PEEP of 5-6 cm for 72 hours post extubation
Receives: Device: NIPPV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment failure

    1. Treatment failure during the first 72 hours post-extubation.
    2. Reintubation (failure of extubation) within 72 hours' post extubation.

    Treatment failure is defined as:

    • Hypoxia (FiO 2 requirement > 0.35)
    • Respiratory acidosis defined as pH < 7.2 \& PCo2> 60 mmHg
    • Major apnea requiring mask ventilation or > 4 episodes/ hour.

    The protocol will discontinue according to treatment failure criteria as mentioned above.

    Rescue treatment with NIPPV will be allowed and will be considered as treatment failure

    Measured: 72 hours

Secondary outcomes (9)

  1. Death prior to discharge

    Death

    Measured: 90 days from birth

  2. Intraventricular haemorrhage IVH (grades III & IV)

    defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement

    Measured: 7 days after extubation

  3. Pneumothorax

    diagnosed radiologically

    Measured: 7 days after extubation

  4. Bronchopulmonary dysplasia (BPD)

    defined as requirement for supplemental oxygen at 28 days of life or requirement for supplemental oxygen at 36 weeks' postmenstrual age

    Measured: 36 weeks' postmenstrual age

  5. Necrotizing enterocolitis

    defined according to modified Bell's criteria (stage 2 to 3)

    Measured: 7 days after extubation

  6. Gastrointestinal perforation

    diagnosed radiologically or at operation

    Measured: 7 days after extubation

  7. Nosocomial sepsis

    defined as positive blood or cerebrospinal fluid (CSF) cultures taken after five days of age

    Measured: 7 days after extubation

  8. Retinopathy of prematurity (ROP)

    stage 3 or greater (International classification)

    Measured: 40 weeks corrected postnatal age

  9. Duration of hospitalisation or Length of stay (in days)

    Number of days in hospital until first discharge

    Measured: From admission to first discharge from hospital, assessed up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2018
  2. Study start1 May 2017
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled trial * A web generated a block randomisation list. * A block of 4, stratification based on GA, gender \& antenatal steriods * Sequentially numbered, opaque and sealed envelopes * Restricted access to envelopes
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03388437
Sponsor's protocol ID
REC 202
Status last verified
Jul 2021
First submitted
16 Dec 2017
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.

    PubMed 26178463

  • Stein H, Howard D. Neurally adjusted ventilatory assist in neonates weighing <1500 grams: a retrospective analysis. J Pediatr. 2012 May;160(5):786-9.e1. doi: 10.1016/j.jpeds.2011.10.014. Epub 2011 Dec 3.

    PubMed 22137670

Questions about this trial

What is this clinical trial studying?

A study testing NI-NAVA and NIPPV in people with Prematurity and Respiratory Failure, run by King Fahad Armed Forces Hospital at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment failure (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03388437, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.

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