Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants
NCT ID: NCT02421328
Last Updated: 2017-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2015-05-31
2016-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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CPAP first
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
CPAP first (Fisher & Paykel Healthcare)
Infants will start on nasal CPAP for 60 minutes and then switched to HHHFNC for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
HHHFNC first
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
HHHFNC first (Fisher & Paykel Healthcare)
Infants will start on HHHFNC for 60 minutes and then switched to nasal CPAP for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
Interventions
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CPAP first (Fisher & Paykel Healthcare)
Infants will start on nasal CPAP for 60 minutes and then switched to HHHFNC for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
HHHFNC first (Fisher & Paykel Healthcare)
Infants will start on HHHFNC for 60 minutes and then switched to nasal CPAP for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
Eligibility Criteria
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Inclusion Criteria
* Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
* On less than 35% oxygen.
Exclusion Criteria
* 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.
1 Month
ALL
No
Sponsors
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Mansoura University Children Hospital
OTHER
Responsible Party
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Hesham Abdel-Hady
Professor of Pediatrics
Locations
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Neonatal Intensive Care Unit, Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate, Egypt
NICU, Mansoura University Children's Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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References
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El-Mogy M, El-Halaby H, Attia G, Abdel-Hady H. Comparative Study of the Effects of Continuous Positive Airway Pressure and Nasal High-Flow Therapy on Diaphragmatic Dimensions in Preterm Infants. Am J Perinatol. 2018 Apr;35(5):448-454. doi: 10.1055/s-0037-1608682. Epub 2017 Nov 13.
Other Identifiers
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MS 874
Identifier Type: -
Identifier Source: org_study_id
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