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

Bnai Zion Medical Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Distress Syndrome

Interventions

NIMV with SLE ventilator vs HFNC via VapothermDEVICE

Nasal respiratory support for RDS

Eligibility

Sex: ALLMin age: 1 Minute

Medical Language ↔ Plain English

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.

Locations (1)

Bnai Zion Medical Center, Neonatal department

Haifa, Israel

RECRUITING

Outcomes

Primary Outcomes

The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS.

Time frame: 1 year

Secondary Outcomes

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"

Time frame: 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.

Time frame: 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

Time frame: 1 year

Data from ClinicalTrials.gov

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