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Completed

NCT Number: NCT07000071

Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants

The aim of the present work is to compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need for reintubation. Additionally, the study aims at comparing between the three modes concerning the associated morbidity and mortality.

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Key information

Conditions

Neonates Dyspnea Non- Invasive Ventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Mohamed Farag

Alexandria, 0325, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The gestational age (GA) is between 34 and 41 weeks.
  • Extubation from invasive mechanical ventilation initiated due to RD, irrespective to the cause of RD.
  • Respiratory distress is assessed based on clinical manifestations (tachypnea, nasal flaring, intercostal retractions, diminished air entry, and or grunting)

Exclusion criteria

  • Major congenital anomalies.
  • Major cardiac diseases.
  • Presence of cardiovascular instability (sepsis, severe dehydration, severe anemia).
  • Neurologically insulted neonates who are unable to take adequate spontaneous breathing.

Treatment and study plan

NCPAP

Device

Apply nasal continuous positive airway pressure in intubated patients with respiratory distress at time of weaning

NIPPV

Device

Apply nasal intermittent positive pressure ventilation in intubated patients with respiratory distress at time of weaning

NHFOV

Device

Apply nasal high frequency ventilation in intubated patients with respiratory distress at time of weaning

Primary outcomes

  1. Failure rate

    Time frame: 72 hours after weaning

    need for reintubation and invasive mechanical ventilation

Secondary outcomes

  1. duration of non-invasive ventilation

    Time frame: first 72 hours after weaning from mechanical ventillation

    duration of noninvasive ventilation till patients become weaned to free flow oxygen

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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