Noninvasive High Frequency Oscillation Ventilation (NHFOV) in Comparison to Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) As Post-extubation Support in Preterm Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kafrelsheikh University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- reintubation and the duration of respiratory support
Study Overview
Brief Summary
comparison between Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) and Noninvasive High Frequency Oscillation Ventilation (NHFOV) post-extubation in preterm neonates as regards the efficacy and their possible complications.
Detailed Description
The global definition of preterm infant by the World Health Organization is any infant born before 37 weeks of gestation. Annually, an estimated 15 million (11.1%) preterm infants are born worldwide. Preterm birth is further classified as extremely preterm (<28 weeks), very preterm (28 to <32 weeks), and moderate (32 to <34 weeks) to late preterm (34 to <37 weeks).
Prematurity has been associated with several risk factors, such as history of previous preterm birth, pregnancy induced hypertension, premature rupture of fetal membranes, multiple pregnancy, bleeding during pregnancy, history of abortion, fetal malformation, inadequate antenatal care, polyhydramnios and previous caesarean section.
Preterm neonates are at greater risk of a range of short-term and long-term morbidities. Respiratory distress syndrome (RDS) is one of the most common causes of morbidity and mortality in preterm infants. RDS is characterized by a lack of lung surfactant. Insufficient surfactant production or secretion results in higher alveolar surface tension, leading to atelectasis and impaired gas exchange. Respiratory distress typically manifests in newborns as tachypnea, intercostal retractions, nasal flaring, grunting, and cyanosis.
Invasive mechanical ventilation (IMV) increases survival in preterm infants with severe RDS. However, prolonged intubation and mechanical ventilation of preterm infants increases the risk of life-threatening complications including, ventilator induced lung injury and airway inflammation leading to bronchopulmonary dysplasia, and nosocomial pneumonia, and also increases the risk of a poor neurodevelopmental outcome. Therefore, when caring for premature infants, clinicians should focus on weaning from IMV as expeditiously as possible to noninvasive respiratory support (NRS).
There are many strategies and criteria for weaning, including evaluation of ventilatory parameters, clinical/biochemical criteria, and predictive indices of extubation that can be followed by or combined with spontaneous breathing trials or gradual withdrawal from ventilatory support.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm neonates with gestational age between 32 and 36 weeks and on mechanical ventilation ready to be extubated.
- •When the case is ready for extubation , will receive at least one loading dose of caffeine citrate (20 mg/kg/dose) and daily maintenance dose of 5 mg/kg/dose.
- •Criteria for extubation:
- •Blood gas analysis: PH > 7.25 and PaCO2 ≤ 60 mmHg.
- •Airway pressure (Paw) of 7 to 8 cmH2O.
- •Required fraction of inspired oxygen (FiO2) ≤ 30%.
- •Sufficient spontaneous breathing by clinical evaluation.
Exclusion Criteria
- •Full term neonates.
- •Preterm neonates who will not require intubation.
- •Preterm neonates with one of the following criteria:
- •birth weight > 900 gms , major congenital anomalies, upper airway anomalies, neuromuscular diseases, surgical cases, intraventricular hemorrhage grade IV.
- •Cases that require reintubation after more than 72 hours of extubation.
Arms & Interventions
Noninvasive high frequency oscillation ventilation
preterm neonates with GA of 32 to 36 weeks ready for extubation
Intervention: noninvasive high frequency oscillation ventilation (Device)
Noninvasive intermittent positive pressure ventilation
preterm neonates with GA of 32 to 36 weeks ready for extubation
Intervention: noninvasive positive pressure ventilation (Device)
Outcomes
Primary Outcomes
reintubation and the duration of respiratory support
Time Frame: from the date of birth till the date of discharge from NICU or death (assessed up to 3 months)..
* The number of cases that required re-intubation and the time of failure of extubation in hours. * Duration of different types of respiratory support since birth till discharge from NICU.
Secondary Outcomes
- complications(from the date of birth till the date of discharge from NICU or death (assessed up to 3 months).)
Investigators
Wafaa Mahmoud Hassan Abouseada
pediatric demonstrator at faculty of medicine- kafrelsheikh university
Kafrelsheikh University