A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure

NCT04051762 | Completed

• 1 other identifier: Post extubation HFNC vs. NCPAP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that there is a growing trend of the feasibility of HFNC as an alternative to other forms of non-invasive ventilation mechanism to provide continuous distending pressure to preterm infants. However, there remains uncertainty about the efficacy and safety of HFNC in this population.

Conditions

Neonatal Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• postextubation respiratory support

  compare successful extubation of preterm (less than 34 weeks) into high flow nasal cannula versus continues positive airway pressure.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• postextubation respiratory support follow up

  through study completion, an average of 1 year

Study Arms (2)

Preterm neonates on HFNC

neonates extubated to HFNC (High flow nasal cannula)

Device: High flow nasal cannula vs. Nasal continuous positive airway pressure

Preterm neonates on NCPAP

neonates extubated to NCPAP ( nasal continuous positive airway pressure)

Device: High flow nasal cannula vs. Nasal continuous positive airway pressure

Interventions

High flow nasal cannula vs. Nasal continuous positive airway pressure DEVICE

High flow nasal cannula

Preterm neonates on HFNC; Preterm neonates on NCPAP

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The following study will be conducted in the neonatal intensive care unit (NICU) of Gynecology and Obstetric department of Kasr El Aini hospital and neonatal intensive care unit of Military Hospital throughout a time interval of at least 6 months for a minimum of 100 preterm infants. Infants will be eligible for the study if they born at less than 34 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and considered ready for extubation by the clinical team.

You may qualify if:

• Infants born at a gestational age of less than 34 weeks, receiving mechanical ventilation through an endotracheal tube.

You may not qualify if:

• Full term neonates or large for gestational age.
• Preterm neonates not supported primarily by invasive ventilation.
• Infants with suspected upper airway obstruction, congenital airway malformations or major cardiopulmonary malformations.

Sponsors & Collaborators

• Ramy Saleh Morsy: lead

Study Sites (1)

Magda Mahmoud Badawy

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistatnt Lecturer in AFCM

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: August 9, 2019
• Study Start: June 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: July 30, 2018
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)