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The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants.
The main question it aims to answer is:
• Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 >0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LISA with NCPAP | Active Comparator | In this group, infants will receive NCPAP during LISA procedure. |
|
| LISA with NIPPV | Experimental | In this group, infants will receive NIPPV during LISA procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Intermittent Positive Pressure Ventilation (NIPPV) | Procedure | In this group, infants will receive NIPPV during LISA procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surfactant or mechanical ventilation | Need for a second dose of surfactant or mechanical ventilation | The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life |
| Measure | Description | Time Frame |
|---|---|---|
| Noninvasive ventilation | Duration of noninvasive ventilation | Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks |
| Mechanical ventilation | Duration ofmechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Careggi University Hospital, Division of Neonatology | Florence | 50141 | Italy |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Nasal continuous positive airway pressure (NCPAP) | Procedure | In this group, infants will receive NCPAP during LISA procedure. |
|
| Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks |
| Bronchopulmonary dysplasia | Frequency of mild, moderate, and severe bronchopulmonary dysplasia | Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012138 |
| Respiratory Therapy |