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

Mansoura University Children Hospital24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respirtory Distress

Interventions

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.

Eligibility

Sex: ALLMax age: 1 Month

Medical Language ↔ Plain English

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.

Locations (2)

Neonatal Intensive Care Unit, Mansoura University Children Hospital

Al Mansurah, Dakahlia Governorate, Egypt

NICU, Mansoura University Children's Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

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

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.

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

Right and left diaphragmatic excursion

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.

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

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

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.

Data from ClinicalTrials.gov

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