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

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

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 Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Device: NIMV with SLE ventilator vs HFNC via Vapotherm

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Bnai Zion Medical Center, Neonatal department
    • Principal Investigator: Amir Kugelman, MD
    • Contact: Amir Kugelman, MD; Phone Number: 972-4-8359559

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Principal Investigator: Amir Kugelman, MD, Bnai Zion Medical Cente

Publications and helpful links

General Publications

• Kugelman A, Feferkorn I, Riskin A, Chistyakov I, Kaufman B, Bader D. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for respiratory distress syndrome: a randomized, controlled, prospective study. J Pediatr. 2007 May;150(5):521-6, 526.e1. doi: 10.1016/j.jpeds.2007.01.032.
• Kugelman A, Riskin A, Said W, Shoris I, Mor F, Bader D. A randomized pilot study comparing heated humidified high-flow nasal cannulae with NIPPV for RDS. Pediatr Pulmonol. 2015 Jun;50(6):576-83. doi: 10.1002/ppul.23022. Epub 2014 Mar 12.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Primary treatment of RDS and treatment of RDS post extubation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 31/09