High Flow Nasal Cannula (HFNC) Versus Nasal Intermittent Mandatory Ventilation (NIMV)for Respiratory Distress Syndrome (RDS): a Randomized, Controlled, Prospective Study

Study Overview
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Brief Summary
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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.

Official Title
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High Flow Nasal Cannula Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome: a Randomized, Controlled, Prospective Study

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Device: NIMV with SLE ventilator vs HFNC via Vapotherm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 24 to 34 and 6/7 weeks assessed by the obstetrical team from dating of last menstural period or ultrasound and weight >1000 g for the initial treatment of RDS or <35 weeks post extubation or for apnea of prematurity Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent. Exclusion Criteria: Significant morbidity apart from RDS including: cardiac disease (not including patent ductus arteriosus [PDA]), congenital malformation, or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (IVH), Parents refuse consent. Unavailability of suitable ventilator.

Ages Eligible for Study
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Minimum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIMV- nasal respiratory support<br>Infants with RDS will be treateg with nasal intermittent mandatory ventilation | Device: NIMV with SLE ventilator vs HFNC via Vapotherm<br>* Nasal respiratory support for RDS<br>* Other names: NIMV with SLE ventilator vs. HFNC via Vapotherm;|
| Experimental: HFNC- nasal respiratory support with HFNC<br>Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla | Device: NIMV with SLE ventilator vs HFNC via Vapotherm<br>* Nasal respiratory support for RDS<br>* Other names: NIMV with SLE ventilator vs. HFNC via Vapotherm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary treatment of RDS and treatment of RDS post extubation