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

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ClinicalTrials.gov Identifier: NCT03388437
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Raniah Aljeaid, King Fahad Armed Forces Hospital

Brief 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 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 .

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.


Condition or disease Intervention/treatment Phase
Prematurity Respiratory Failure Ventilator Lung; Newborn Device: NI-NAVA Device: NIPPV Not Applicable

Detailed Description:

Study Design: Randomised controlled trial

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation: A Randomised Control Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: NI-NAVA
Initial 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
Device: NI-NAVA

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

Active Comparator: NIPPV
Initial 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
Device: NIPPV

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




Primary Outcome Measures :
  1. Treatment failure [ Time Frame: 72 hours ]
    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



Secondary Outcome Measures :
  1. Death prior to discharge [ Time Frame: 90 days from birth ]
    Death

  2. Intraventricular haemorrhage IVH (grades III & IV) [ Time Frame: 7 days after extubation ]
    defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement

  3. Pneumothorax [ Time Frame: 7 days after extubation ]
    diagnosed radiologically

  4. Bronchopulmonary dysplasia (BPD) [ Time Frame: 36 weeks' postmenstrual age ]
    defined as requirement for supplemental oxygen at 28 days of life or requirement for supplemental oxygen at 36 weeks' postmenstrual age

  5. Necrotizing enterocolitis [ Time Frame: 7 days after extubation ]
    defined according to modified Bell's criteria (stage 2 to 3)

  6. Gastrointestinal perforation [ Time Frame: 7 days after extubation ]
    diagnosed radiologically or at operation

  7. Nosocomial sepsis [ Time Frame: 7 days after extubation ]
    defined as positive blood or cerebrospinal fluid (CSF) cultures taken after five days of age

  8. Retinopathy of prematurity (ROP) [ Time Frame: 40 weeks corrected postnatal age ]
    stage 3 or greater (International classification)

  9. Duration of hospitalisation or Length of stay (in days) [ Time Frame: From admission to first discharge from hospital, assessed up to 6 months ]
    Number of days in hospital until first discharge



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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Major congenital malformations or respiratory abnormalities
  2. Neuromuscular disease
  3. phrenic nerve palsy
  4. Intraventricular hemorrhage (IVH) grade III or IV
  5. Absence of informed consent
  6. Out born infants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388437


Contacts
Contact: Raniah Aljeaid (966-12)2328888 rania_aljeaid@yahoo.com
Contact: Nisreen Kafi (966-12)2328888 nkafi@yahoo.com

Locations
Saudi Arabia
King Fahad Armed Forces Hospital Recruiting
Jeddah, Saudi Arabia, 21159
Contact: Raniah Aljeaid    (966-12)2328888    rania_aljeaid@yahoo.com   
Contact: Nisreen Kafi    (966-12)2328888    nkafi@yahoo.com   
Sponsors and Collaborators
King Fahad Armed Forces Hospital
Investigators
Principal Investigator: Raniah Aljeaid King Fahad Armed Forces Hospital Jeddah
Study Director: Nisreen Kafi King Fahad Armed Forces Hospital Jeddah
Study Director: Fawzia Sabbagh King Fahad Armed Forces Hospital Jeddah
Study Chair: Mai Abu Seoud King Fahad Armed Forces Hospital Jeddah

Publications of Results:
Responsible Party: Dr. Raniah Aljeaid, Neonatal Fellow, King Fahad Armed Forces Hospital
ClinicalTrials.gov Identifier: NCT03388437     History of Changes
Other Study ID Numbers: REC 202
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Raniah Aljeaid, King Fahad Armed Forces Hospital:
Non-invasive Neurally Adjusted Ventilatory Assist NI-NAVA
Nasal Intermittent Positive Pressure Ventilation NIPPV
post extubation

Additional relevant MeSH terms:
Respiratory Insufficiency
Bronchopulmonary Dysplasia
Respiration Disorders
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases