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Non Invasive Positive Pressure Ventilation (NIPPV) or conventional mechanical ventilation for neonatal respiratory failure

Non Invasive positive pressure ventilation( NIPPV )or conventional mechanical ventilation for treatment of respiratory failure and CPAP failure in premature infants hospitalized in Alzahra and Shahid behesthi hospitals in Isfahan.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000346774
Enrollment
50
Registered
2013-04-02
Start date
2012-11-28
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

RDS and its sequelae BPD, are both frequent complications of prematurity that may requires respiratory support.because mechanical ventilation (by endoteracheal ventilation) is associated with high morbidity,today an effort to decrease ventilator induced lung injury,alternative techniques of ventilation have been employed.NIPPV is a noninvasive approach for ventilation.The benefits of NIPPV use for infants with NCPAP failure is not studied yet.So our purpose is to compare two modalities;NIPPV and conventional ventilation(CV) for treatment of respiratory failure in preterm neonates.This prospective clinical trial performs on 50 patients with GA<35 weeks and Birth Weight <2500g that have CPAP failure and admitted in NICU of Alzahra and Shahid Beheshti hospitals in Isfahan.The randomization is performed applying minimization technique with respect to baby's gender and Birth weight and the newborns will devided into two groups;NIPPV and CV.We will also assess the incidence of complications such as pneumothorax,IVH,BPD,NEC and PDA in our trial.

Interventions

Nasal intermittent positive pressure ventilation (NIPPV) involves giving continuous positive airway pressure (CPAP) to the infant in the intermittent mandatory ventilation (IMV) mode that have advocated as a means to wean infants from mechanical ventilation(by nasal root).We have found NIPPV more effective than nasal continuous positive airway pressure(NCPAP) in weaning infants with RDS from mechanical ventilation and have recommended that NIPPV be used as the modality of choice for extubation.

Nasal intermittent positive pressure ventilation (NIPPV) involves giving continuous positive airway pressure (CPAP) to the infant in the intermittent mandatory ventilation (IMV) mode that have advocated as a means to wean infants from mechanical ventilation(by nasal root).We have found NIPPV more effective than nasal continuous positive airway pressure(NCPAP) in weaning infants with RDS from mechanical ventilation and have recommended that NIPPV be used as the modality of choice for extubation.because mechanical ventilation (by endoteracheal ventilation) is associated with high morbidity,today an effort to decrease ventilator induced lung injury,alternative techniques of ventilation have been employed.we administered NIPPV when the patient have CPAP failure and it will continue till wean from NIPPV(with frequent arterial blood gass(ABG).We will also assess the incidence of complications such as pneumothorax, intra ventricular hemorrhage(IVH), broncho pulmonary dysplasia(BPD), necrotizing enterocolitis(NEC) and patient dactus arteriosus(PDA) in our trial.

Sponsors

Isfahan university of medical sciences
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to 1 Months
Healthy volunteers
No

Inclusion criteria

inclusion criteria: All consecutively born preterm infants with gestational age less than 35 weeks and birth weight less than 2500g treated with NCPAP that have CPAP failure (Fio2 more than 60% and max CPAP equal to 8 cmH2O and/or PH less than 7.2 and PCO2 more than 60 and/or more than 3 episodes apnea with bradicardia (heart rate less than 80 per minute in 20,31,35hr).

Exclusion criteria

exclusion criteria: babies were excluded if there was nasopharyngeal pathology including coanal atresia,cleft/lip palate,major anomalies especially thorasic or cardiac anomalies,IVH grade 3 or 4 on admission and their parents refuse to participate in the research project.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026