Clinical Trials Directory

Trials / Completed

CompletedNCT02421328

Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants

Comparative Study of the Effects of Continuous Positive Airway Pressure and Heated, Humidified High Flow Nasal Cannula on Diaphragmatic Dimensions in Preterm Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Mansoura University Children Hospital · Academic / Other
Sex
All
Age
1 Month
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICECPAP 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.
DEVICEHHHFNC 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.

Timeline

Start date
2015-05-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2015-04-20
Last updated
2017-03-13

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02421328. Inclusion in this directory is not an endorsement.