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The investigators hypothesize that while the extremely low birthweight (ELBW) infants (<1000 g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post extubation may enjoy the comfort benefits associated with HFNC while getting coparable respiratory support to NIMV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIMV- nasal respiratory support | Experimental | Infants with RDS will be treateg with nasal intermittent mandatory ventilation |
|
| HFNC- nasal respiratory support with HFNC | Experimental | Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIMV with SLE ventilator vs HFNC via Vapotherm | Device | Nasal respiratory support for RDS |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical features on both methods | Blood pressure, heart rate, respiratory rate, pulse oximetry saturation, and respiratory status prior to mechanical ventilation if needed according to arterial blood gas (PaO2, PCO2, pH), and "time to stop nasal support" | 1 year |
| % of infants with neonatal morbidities on both methods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Kugelman, MD | Bnai Zion Medical Cente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center, Neonatal department | Recruiting | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17452229 | Background | Kugelman A, Feferkorn I, Riskin A, Chistyakov I, Kaufman B, Bader D. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for respiratory distress syndrome: a randomized, controlled, prospective study. J Pediatr. 2007 May;150(5):521-6, 526.e1. doi: 10.1016/j.jpeds.2007.01.032. | |
| 24619945 | Derived |
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|
Incidence of intraventricular hemorrhage (IVH), duration of mechanical ventilation, incidence of BPD (oxygen at 36 weeks post conceptional age to keep saturation>92%), time until full feeds, and length of stay. |
| 1 year |
| % of infants with possible side effects on both methods | Nasal trauma due to NRS, rate of air leak (pneumothorax), gastrointestinal perforation, irritability and discomfort assessed by a validated score | 1 year |
| Kugelman A, Riskin A, Said W, Shoris I, Mor F, Bader D. A randomized pilot study comparing heated humidified high-flow nasal cannulae with NIPPV for RDS. Pediatr Pulmonol. 2015 Jun;50(6):576-83. doi: 10.1002/ppul.23022. Epub 2014 Mar 12. |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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