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

Not Applicable

Completed

• Conditions: Prematurity; Ventilator Lung; Newborn; Respiratory Failure
• Interventions: Device: NIPPV; Device: NI-NAVA

• Registration Number: NCT03388437
• Lead Sponsor: 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.

Detailed Description

Study Design: Randomised controlled trial

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

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-12-16
• Study First Submitted QC: 2017-12-24
• Study First Posted: 2018-01-03
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-25
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIPPV	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
NI-NAVA	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

Primary Outcome Measures

Name	Time	Method
Treatment failure	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

Name	Time	Method
Death prior to discharge	90 days from birth	Death
Intraventricular haemorrhage IVH (grades III & IV)	7 days after extubation	defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement
Pneumothorax	7 days after extubation	diagnosed radiologically
Bronchopulmonary dysplasia (BPD)	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
Necrotizing enterocolitis	7 days after extubation	defined according to modified Bell's criteria (stage 2 to 3)
Gastrointestinal perforation	7 days after extubation	diagnosed radiologically or at operation
Nosocomial sepsis	7 days after extubation	defined as positive blood or cerebrospinal fluid (CSF) cultures taken after five days of age
Retinopathy of prematurity (ROP)	40 weeks corrected postnatal age	stage 3 or greater (International classification)
Duration of hospitalisation or Length of stay (in days)	From admission to first discharge from hospital, assessed up to 6 months	Number of days in hospital until first discharge

Trial Locations

Locations (1)

King Fahad Armed Forces Hospital; 🇸🇦 Jeddah, Saudi Arabia