Clinical trial NCT04238273: High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure for Respiratory Support of Preterm Neonates
Official title: Hemodynamic Changes With Heated, Humidified High Flow Nasal Cannula (HHHFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Support of Preterm Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: Hemodynamic changes
High flow nasal cannula
Nasal continuous positive airway pressure
Respiratory distress syndrome
Prematurity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 123
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted on preterm neonates who required ventilatory support for respiratory distress syndrome (RDS) with previous invasive ventilation or not. The involved study group will be of matched gestational, postnatal age and sex.

Brief summary: This work is designed to:

1. Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
2. Investigate hemodynamic changes associated with HHHFNC in comparison to nCPAP in preterm neonates during periods of non-invasive respiratory support and after being off support.

Detailed description: There is a preference of using noninvasive modes of ventilation for management of respiratory distress syndrome (RDS) in preterm infants and of weaning of ventilated neonates as soon as possible to non-invasive modes.

Yet, little is known about which non-invasive mode is better and the hemodynamic changes that occur to the infants secondary to these modes. The study provides an evaluation of the efficacy of heated, humidified high flow nasal cannula (HHHFNC) in comparison to nasal continuous positive airway pressure (nCPAP) in preterm infants. Secondary aim is to assess echographic, cerebral blood flow and mesenteric blood flow changes during HHHFNC versus nCPAP.

Eligibility criteria: Inclusion Criteria:

Infants are eligible if they meet the following criteria:

1. Gestational age ≤ 35 weeks.
2. Preterm neonates in need for non invasive ventilation whether they were on invasive ventilatory support before or not.

Exclusion Criteria:

Preterm neonates with evidence of any of the following will be excluded:

1. Major upper or lower airway anomalies.
2. Significant congenital anomalies including cardiac, abdominal or respiratory.
3. Hemodynamically significant patent ductus arteriosus (PDA): diagnosed if there is colour doppler echocardiographic evidence of left to right ductal shunt, ductal diameter \>1.5mm/kg or left atrial/aortic root ratio \>1.4

Primary outcomes:
measure: Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
timeFrame: 2 years
measure: Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index).
timeFrame: 2 years
measure: Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec)
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: 38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department
Study officials:
affiliation: Ain Shams University,Medical school, Pediatrics department
name: Prof. Hisham Abdel Samie Awad
role: STUDY_DIRECTOR
References: