NCT01189162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

6.5 years

First QC Date

August 23, 2010

Last Update Submit

August 11, 2015

Conditions

Respiratory Distress Syndrome

Keywords

Primary treatment of RDS and treatment of RDS post extubation

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (3)

  • Clinical features on both methods

    1 year

  • % of infants with neonatal morbidities on both methods

    1 year

  • % of infants with possible side effects on both methods

    1 year

Study Arms (2)

NIMV- nasal respiratory support

EXPERIMENTAL

Infants with RDS will be treateg with nasal intermittent mandatory ventilation

Device: NIMV with SLE ventilator vs HFNC via Vapotherm

HFNC- nasal respiratory support with HFNC

EXPERIMENTAL

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

Device: NIMV with SLE ventilator vs HFNC via Vapotherm

Interventions

NIMV with SLE ventilator vs HFNC via VapothermDEVICE

Nasal respiratory support for RDS

Also known as: NIMV with SLE ventilator vs. HFNC via Vapotherm
HFNC- nasal respiratory support with HFNCNIMV- nasal respiratory support

Eligibility Criteria

Age1 Minute+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent.

You may not qualify if:

  • 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),
  • Parents refuse consent.
  • Unavailability of suitable ventilator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center, Neonatal department

Haifa, Israel

RECRUITING

Related Publications (2)

  • 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.

    PMID: 17452229BACKGROUND

  • 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.

    PMID: 24619945DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Amir Kugelman, MD

    Bnai Zion Medical Cente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 26, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

IL(1)