High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure for Respiratory Support of Preterm Neonates

NCT04238273 | Completed

• 1 other identifier: FMASU MD 386/2017
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

This work is designed to:

1. 1.Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
2. 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.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Hemodynamic changes; High flow nasal cannula; Nasal continuous positive airway pressure; Respiratory distress syndrome; Prematurity

Outcome Measures

Primary Outcomes (1)

• Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.

  Done using Bedside functional echocardiography to record Superior vena caval flow (ml/kg/min), right ventricular output flow (ml/kg/min) and left ventricular output flow (ml/kg/min) for each preterm neonate in one of the two study groups (using either HHHFNC and nCPAP) on and off respiratory support.

  2 years

Secondary Outcomes (3)

• Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.

  2 years

• Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index).

  2 years

• Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec)

  2 years

Study Arms (2)

HHHFNC

it included 63 preterm neonates on Heated, Humidified High Flow Nasal Cannula, of which 35 preterm underwent functional echocardiography, transcranial ultrasonography Doppler applied to the anterior cerebral artery and assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography. All of which done while on non invasive ventilation and after weaning.

Diagnostic Test: Functional Echocardiography

NCPAP

it included 60 preterm neonates on Nasal Continuous Positive Airway Pressure, of which 35 preterm underwent functional echocardiography, transcranial ultrasonography Doppler applied to the anterior cerebral artery and assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography. All of which done while on non invasive ventilation and after weaning.

Diagnostic Test: Functional Echocardiography

Interventions

Functional Echocardiography DIAGNOSTIC_TEST

Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation

Also known as: Transcranial ultrasonography Doppler applied to the anterior cerebral artery, Assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography

HHHFNC; NCPAP

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Infants are eligible if they meet the following criteria:
• Gestational age ≤ 35 weeks.
• Preterm neonates in need for non invasive ventilation whether they were on invasive ventilatory support before or not.

You may not qualify if:

• Preterm neonates with evidence of any of the following will be excluded:
• Major upper or lower airway anomalies.
• Significant congenital anomalies including cardiac, abdominal or respiratory.
• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department

Cairo, 11517, Egypt

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Prof. Hisham Abdel Samie Awad

  Ain Shams University,Medical school, Pediatrics department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 23, 2020
• Study Start: January 31, 2018
• Primary Completion: November 30, 2019
• Study Completion: January 1, 2020
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

EG (1)