Clinical trial NCT03388437: Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation
Official title: Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Respiratory Failure
Ventilator Lung; Newborn
Keywords: Non-invasive Neurally Adjusted Ventilatory Assist NI-NAVA
Nasal Intermittent Positive Pressure Ventilation NIPPV
post extubation
Lead sponsor: King Fahad Armed Forces Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-03
Enrollment: 36
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Treatment failure
timeFrame: 72 hours
Secondary outcomes:
measure: Death prior to discharge
timeFrame: 90 days from birth
measure: Intraventricular haemorrhage IVH (grades III & IV)
timeFrame: 7 days after extubation
measure: Pneumothorax
timeFrame: 7 days after extubation
measure: Bronchopulmonary dysplasia (BPD)
timeFrame: 36 weeks' postmenstrual age
measure: Necrotizing enterocolitis
timeFrame: 7 days after extubation
measure: Gastrointestinal perforation
timeFrame: 7 days after extubation
measure: Nosocomial sepsis
timeFrame: 7 days after extubation
measure: Retinopathy of prematurity (ROP)
timeFrame: 40 weeks corrected postnatal age
measure: Duration of hospitalisation or Length of stay (in days)
timeFrame: From admission to first discharge from hospital, assessed up to 6 months
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
Study officials:
affiliation: King Fahad Armed Forces Hospital Jeddah
name: Raniah Aljeaid
role: PRINCIPAL_INVESTIGATOR
affiliation: King Fahad Armed Forces Hospital Jeddah
name: Nisreen Kafi
role: STUDY_DIRECTOR
affiliation: King Fahad Armed Forces Hospital Jeddah
name: Fawzia Sabbagh
role: STUDY_DIRECTOR
affiliation: King Fahad Armed Forces Hospital Jeddah
name: Mai Abu Seoud
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.