Respiratory Distress Syndrome
Conditions
Keywords
Primary treatment of RDS and treatment of RDS post extubation
Brief summary
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.
Interventions
DEVICENIMV with SLE ventilator vs HFNC via Vapotherm
Nasal respiratory support for RDS
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent.
Exclusion criteria
1. 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), 2. Parents refuse consent. 3. Unavailability of suitable ventilator.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical features on both methods | 1 year | 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 |
| % of infants with neonatal morbidities on both methods | 1 year | 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. |
| % of infants with possible side effects on both methods | 1 year | Nasal trauma due to NRS, rate of air leak (pneumothorax), gastrointestinal perforation, irritability and discomfort assessed by a validated score |
Countries
Israel
Outcome results
None listed