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

NCT03388437 | Completed

• 1 other identifier: REC 202
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Respiratory Failure; Ventilator Lung; Newborn

Keywords

Non-invasive Neurally Adjusted Ventilatory Assist NI-NAVA; Nasal Intermittent Positive Pressure Ventilation NIPPV; post extubation

Outcome Measures

Primary Outcomes (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

  72 hours

Secondary Outcomes (9)

• Death prior to discharge

  90 days from birth

• Intraventricular haemorrhage IVH (grades III & IV)

  7 days after extubation

• Pneumothorax

  7 days after extubation

• Bronchopulmonary dysplasia (BPD)

  36 weeks' postmenstrual age

• Necrotizing enterocolitis

  7 days after extubation

Study Arms (2)

NI-NAVA

EXPERIMENTAL

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

NIPPV

ACTIVE COMPARATOR

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

Interventions

NI-NAVA DEVICE

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

NI-NAVA

NIPPV DEVICE

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

NIPPV

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Fahad Armed Forces Hospital: lead

Study Sites (1)

King Fahad Armed Forces Hospital

Jeddah, 21159, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 26178463 RESULT

• 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.

  PMID: 22137670 RESULT

MeSH Terms

Conditions

Premature Birth; Respiratory Insufficiency; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Raniah Aljeaid

  King Fahad Armed Forces Hospital Jeddah

  PRINCIPAL INVESTIGATOR

• Nisreen Kafi

  King Fahad Armed Forces Hospital Jeddah

  STUDY DIRECTOR

• Fawzia Sabbagh

  King Fahad Armed Forces Hospital Jeddah

  STUDY DIRECTOR

• Mai Abu Seoud

  King Fahad Armed Forces Hospital Jeddah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal Fellow

Model Details: 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

Study Record Dates

• First Submitted: December 16, 2017
• First Posted: January 3, 2018
• Study Start: May 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

SA (1)