Study of the Effects of CPAP and HHHFNC… | Clinical Trial

Key information

Conditions

Respirtory Distress

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NICU, Mansoura University Children's Hospital, Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Preterm infants < 37 weeks.
Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
On less than 35% oxygen.

Exclusion criteria

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.

Treatment and study plan

CPAP first (Fisher & Paykel Healthcare)

Device

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)

Device

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.

Primary outcomes

Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)

Time frame: at the end of each 60 minutes epoch on nasal CPAP

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 nasal CPAP. 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

Time frame: at the end of each 60 minute epoch on CPAP

Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on nasal CPAP. 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.
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)

Time frame: 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

Time frame: 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 outcomes

Respiratory rate

Time frame: 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

Time frame: 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

Time frame: 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
Number of apneas

Time frame: during the 60 minutes epochs on CPAP and HHHFNC

Number of apneas will be recorded during the 60 minutes epoch on CPAP or HHHFNC

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Apr 20, 2015
Registry last updated: Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.