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

Bnai Zion Medical Center

Status: Unknown

Conditions: Respiratory Distress Syndrome

Treatments: Device: NIMV with SLE ventilator vs HFNC via Vapotherm

Study type: Interventional

Funder types: Other

Identifiers

NCT01189162

31/09

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1+ minute old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

NIMV- nasal respiratory support

Experimental group

Description:

Infants with RDS will be treateg with nasal intermittent mandatory ventilation

Treatment:

Device: NIMV with SLE ventilator vs HFNC via Vapotherm

HFNC- nasal respiratory support with HFNC

Experimental group

Description:

Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla

Treatment:

Device: NIMV with SLE ventilator vs HFNC via Vapotherm