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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388437
• Other study ID #: REC 202
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2021
• Source: King Fahad Armed Forces Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

Study Design: Randomised controlled trial Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Prematurity
• Respiratory Failure
• Respiratory Insufficiency
• Ventilator Lung; Newborn

Intervention

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
• 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

Locations

Country	Name	City	State
Saudi Arabia	King Fahad Armed Forces Hospital	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Armed Forces Hospital

Country where clinical trial is conducted

Saudi Arabia, 

References & 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/archdis — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	Treatment failure during the first 72 hours post-extubation.; 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	Death prior to discharge	Death	90 days from birth
Secondary	Intraventricular haemorrhage IVH (grades III & IV)	defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement	7 days after extubation
Secondary	Pneumothorax	diagnosed radiologically	7 days after extubation
Secondary	Bronchopulmonary dysplasia (BPD)	defined as requirement for supplemental oxygen at 28 days of life or requirement for supplemental oxygen at 36 weeks' postmenstrual age	36 weeks' postmenstrual age
Secondary	Necrotizing enterocolitis	defined according to modified Bell's criteria (stage 2 to 3)	7 days after extubation
Secondary	Gastrointestinal perforation	diagnosed radiologically or at operation	7 days after extubation
Secondary	Nosocomial sepsis	defined as positive blood or cerebrospinal fluid (CSF) cultures taken after five days of age	7 days after extubation
Secondary	Retinopathy of prematurity (ROP)	stage 3 or greater (International classification)	40 weeks corrected postnatal age
Secondary	Duration of hospitalisation or Length of stay (in days)	Number of days in hospital until first discharge	From admission to first discharge from hospital, assessed up to 6 months