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

Not Applicable

Recruiting

• Conditions: Respiratory failure; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12613000346774
• Lead Sponsor: Isfahan university of medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eed for Non invasive positive pressure ventilation or Invasive Ventilatory support(conventional mechanical ventilation) Conversion to NIPPV or CV will be recorded as dichotomous data (yes/no).Descriptive statistics; proportions , will be used to describe the measured parameters for each group. Categorical data will be analysed with Chi2 test or Fishers Exact Test as appropriate. All analysis will be intention-to-treat.[During hospitalization and using NIPPV and conventional mechanical ventilation, we will get ABG 1 hour after starting treatment and then every 6 hours until the patient is weaned from the ventilator.]

Secondary Outcome Measures

Name	Time	Method
ecrotizing enterocolitis (NEC) (yes/no) diagnosed on Bell's criteria,will be used to describe the measured parameters for each group[during hospital admission];pneumothorax (yes/no) diagnosed on chest x_ray, will be used to describe the measured parameters for each group.[during hospital admission];patient dactus arteriosus (PDA) (yes/no) diagnosed on echocardiography, will be used to describe the measured parameters for each group.[If patient has the signs and symptoms of PDA 'during hospital admission' echocardiography has done.];bronchopulmonary dysplasis(BPD) (yes/no) diagnosed on chest x_ray.[during hospital admission];Intra ventricular hemorrhage(IVH) (yes/no) diagnosed on cranial ultrasonography,will be used to describe the measured parameters for each group[ In days 1_3 and 7_10 'during hospital admission'.]