Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung Ultrasound

Alexandria University

Status: Enrolling

Conditions: Preterm; Ventilator Lung; Newborn

Treatments: Device: Nasal humidified heated high flow cannula (NHHHC); Device: Nasal continuous positive airway pressure NCPAP; Device: lung ultrasound; Device: Nasal intermittent positive pressure ventilation (NIPPV)

Study type: Interventional

Funder types: Other

Identifiers

NCT06550219

0108428

Details and patient eligibility

About

This study aims to evaluate the effect of non-invasive ventilation (nIPPV)

, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates <37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 24 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Preterm <37 wk. gestational age admitted to the NICU with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).

Exclusion Criteria:

1. Obvious major congenital abnormalities.
2. Any of the baby intubated for resuscitation or for other reasons.
3. Neonates need invasive mechanical ventilation.
4. Pulmonary hemorrhage.
5. Severe cardiovascular instability.
6. Cardiopulmonary arrest needing prolonged resuscitation.
7. Birth asphyxia (one-minute Apgar score ≤ 3).
8. Major cardiac diseases (not including patent ductus arteriosus).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

nasal intermittent positive pressure ventilation group

Experimental group

Treatment:

Device: Nasal intermittent positive pressure ventilation (NIPPV)

Device: lung ultrasound

nasal continuous positive pressure ventilation group

Experimental group

Treatment:

Device: lung ultrasound

Device: Nasal continuous positive airway pressure NCPAP

nasal high flow cannula group

Experimental group

Treatment:

Device: lung ultrasound

Device: Nasal humidified heated high flow cannula (NHHHC)