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

Not Applicable

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: NIMV with SLE ventilator vs HFNC via Vapotherm

• Registration Number: NCT01189162
• Lead Sponsor: Bnai Zion Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNC- nasal respiratory support with HFNC	NIMV with SLE ventilator vs HFNC via Vapotherm	Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla
NIMV- nasal respiratory support	NIMV with SLE ventilator vs HFNC via Vapotherm	Infants with RDS will be treateg with nasal intermittent mandatory ventilation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
% 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.

Trial Locations

Locations (1)

Bnai Zion Medical Center, Neonatal department; 🇮🇱 Haifa, Israel