Effect of High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure

NCT05849116 | Unknown

• 1 other identifier: preterm infants with RDS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Respiratory distress syndrome (RDS) in preterm babies is caused by a deficiency of lung surfactant. The risk of RDS increases with decreasing gestational age, and is almost inevitable in babies born at less than 28 weeks gestation. Without surfactant the lungs become stiff and the alveoli collapse at end-expiration, and untreated RDS is a major cause of morbidity and mortality in preterm infants

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (4)

• The rate of invasive mechanical ventilation at the first 72 hours of life.

  Regarding the following aspect: The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the need for invasive mechanical ventilation at the first 72 hours of life.

  first 72 hours of life

• Time for weaning off from oxygen.

  Regarding the following aspect: The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the time for weaning off from oxygen.

  Baseline

• Duration of hospital stay.

  Regarding the following aspect: The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the duration of hospital stay.

  Baseline

• Rate of morbidity and mortality.

  Regarding the following aspect: The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the effect on morbidity and mortality.

  Baseline

Study Arms (2)

High flow nasal cannula

preterms infants who are connected to high flow nasal cannula

Continuous positive airway pressure

preterms who are connected to continuous positive airway pressure

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

100 preterm infants between 30 weeks and 37 weeks

You may qualify if:

• Preterm infants ≥30 weeks
• Preterm infants with birth weight \>1000 gm
• Preterm infants diagnosed with respiratory distress syndrome.

You may not qualify if:

• Full term infants (\>37 weeks)
• Preterm infants (\<30 weeks \& less than 1000 gm)
• Neonates with respiratory distress other than respiratory distress syndrome.
• Neonates with neonatal sepsis.
• Neonates with congenital anomalies including congenital heart diseases.
• Neonates who need invasive MV immediately after birth.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Gafar Ibrahim, Prof

  Assiut University

  PRINCIPAL INVESTIGATOR

• Safwat Moahmed, Assist prof

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noran Hasan

CONTACT

01067919682; noranhasanmegally2@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 8, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 8, 2023

Record last verified: 2023-05