Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants
- Conditions
- Respirtory Distress
- Interventions
- Device: CPAP first (Fisher & Paykel Healthcare)Device: HHHFNC first (Fisher & Paykel Healthcare)
- Registration Number
- NCT02421328
- Lead Sponsor
- Mansoura University Children Hospital
- Brief Summary
This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants.
- Detailed Description
Preterm infants will be recruited consecutively from NICU of Mansoura University Children's Hospital. They will be randomized in two groups; one group will start on nasal CPAP (Fisher \& Paykel Healthcare, Auckland, New Z ealand) (Pressure 5 cmH2O) for 60 minutes and then will be switched to HHHFNC (Fisher \& Paykel Healthcare, Auckland, New Z ealand) (flow of 4 l/m) for another 60 minutes. The other group will start on HHHFNC and then switched to nasal CPAP.
After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be analyzed in different respiratory cycles and the average of 3 cycles will be calculated at the end of the 60 minutes periods on nasal CPAP and HHHFNC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Preterm infants < 37 weeks.
- Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
- On less than 35% oxygen.
- Congenital and acquired problems of the gastrointestinal tract as necrotizing enterocolitis, esophageal perforation and tracheoesophageal fistula.
- Phrenic nerve injury and/or diaphragm paralysis
- Congenital/acquired neurological deficit and/or seizures
- Hemodynamic instability
- Congenital heart disease (including symptomatic patent ductus arteriosus)
- Undergoing treatment for sepsis or pneumonia.
- Use of muscle relaxants, narcotic analgesics, or gastric motility agents.
- Congenital anomalies of respiratory tract.
- Infants requiring more than 35% oxygen.
- Infants with facial anomalies.
- Infants with pneumothorax and/or pneumomediatinum.
- Infants in the immediate postoperative period.
- Infants with significant gastric residues and vomiting.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CPAP first CPAP first (Fisher & Paykel Healthcare) Infant will be given nasal CPAP for 60 minutes and then put on HHHFNC for another 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on nasal CPAP and HHHFNC. After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team HHHFNC first HHHFNC first (Fisher & Paykel Healthcare) Infant will be given HHHFNC for 60 minutes and then switched to nasal CPAP for another 30 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on HHHFNC and nasal CPAP. After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team
- Primary Outcome Measures
Name Time Method Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness) at the end of each 60 minutes epochs on HHHNC Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on HHHFNC. Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections. All measurements will be performed during quiet breathing. Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Right and left diaphragmatic excursion at the end of each 60 minutes epochs on HHHNC Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on HHHFNC. The displacements of the liver and spleen will be monitored in real-time. Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration. The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion). Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
- Secondary Outcome Measures
Name Time Method Number of apneas during the 60 minutes epochs on CPAP and HHHFNC Number of apneas will be recorded during the 60 minutes epoch on CPAP or HHHFNC
Respiratory rate At the end of each 60 minutes epochs on CPAP and HHHFNC Respiratory rate will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
Heart rate At the end of each 60 minutes epochs on CPAP and HHHFNC Heart rate will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
Spo2 At the end of each 60 minutes epochs on CPAP and HHHFNC Oxygen saturation by pulse oximetry (SpO2) will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
Trial Locations
- Locations (2)
NICU, Mansoura University Children's Hospital
🇪🇬Mansoura, Dakahlia, Egypt
Neonatal Intensive Care Unit, Mansoura University Children Hospital
🇪🇬Mansoura, Dakahlia, Egypt