NCT00356668

Brief Summary

The specific aims of this study are to evaluate the amount of high flow nasal cannula (HFNC) gas flow required to generate an equivalent positive distending pressure as that provided by nasal continuous positive airway pressure (NCPAP) of 6 cm H2O, assess the relationships between positive distending pressure, gas flow, oxygen requirement, and patient weight, and lastly, develop an appropriate protocol to be used in the NICU for transitioning patients from NCPAP to an equivalent amount of HFNC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

First QC Date

July 24, 2006

Last Update Submit

July 13, 2015

Conditions

Respiratory Distress SyndromeCronic Lung Disease

Keywords

HFNCNCPAPnasal continuous positive airway pressurehumidified high flow nasal cannulaesophageal pressuregas flow

Outcome Measures

Primary Outcomes (1)

  • Mean esophageal pressure

    3.5 hours

Secondary Outcomes (1)

  • Vital signs

    3.5 hours

Interventions

High Flow Nasal CannulaDEVICE

30 minute blocks on varying flows of high flow nasal cannula

Eligibility Criteria

Age72 Hours+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \) receiving NCPAP ventilatory support at \> 72 hrs. of age and 2) requiring FiO2 21-50% on NCPAP.

You may not qualify if:

  • FiO2 \>50%, presence of pneumothorax or pleural effusion, anatomical abnormalities of the airway, lungs, or esophagus, or cyanotic congenital heart defect.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (9)

  • Fanaroff & Martin, Ch. 42, pg.1003

    BACKGROUND

  • Jobe AH, Kramer BW, Moss TJ, Newnham JP, Ikegami M. Decreased indicators of lung injury with continuous positive expiratory pressure in preterm lambs. Pediatr Res. 2002 Sep;52(3):387-92. doi: 10.1203/00006450-200209000-00014.

    PMID: 12193673BACKGROUND

  • Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics. 1999 May;103(5 Pt 1):961-7. doi: 10.1542/peds.103.5.961.

    PMID: 10224173BACKGROUND

  • Gittermann MK, Fusch C, Gittermann AR, Regazzoni BM, Moessinger AC. Early nasal continuous positive airway pressure treatment reduces the need for intubation in very low birth weight infants. Eur J Pediatr. 1997 May;156(5):384-8. doi: 10.1007/s004310050620.

    PMID: 9177982BACKGROUND

  • Locke RG, Wolfson MR, Shaffer TH, Rubenstein SD, Greenspan JS. Inadvertent administration of positive end-distending pressure during nasal cannula flow. Pediatrics. 1993 Jan;91(1):135-8.

    PMID: 8416477BACKGROUND

  • Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.

    PMID: 11331690BACKGROUND

  • Ramanathan A, Cayabyab R, et al. High flow nasal cannula use in preterm and term newborns admitted to neonatal intensive care unit: a prospective, observational study. Pediatr Acad Soc 2005; 57:3417

    BACKGROUND

  • Chang GY, Cox CA, Shaffer TH. Nasal cannula, CPAP, and high-flow nasal cannula: effect of flow on temperature, humidity, pressure, and resistance. Biomed Instrum Technol. 2011 Jan-Feb;45(1):69-74. doi: 10.2345/0899-8205-45.1.69.

    PMID: 21322815BACKGROUND

  • Lampland AL, Plumm B, Meyers PA, Worwa CT, Mammel MC. Observational study of humidified high-flow nasal cannula compared with nasal continuous positive airway pressure. J Pediatr. 2009 Feb;154(2):177-82. doi: 10.1016/j.jpeds.2008.07.021. Epub 2008 Aug 30.

    PMID: 18760803DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Mark C Mammel, MD

    Children's Hospital and Clinics of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 26, 2006

Study Start

July 1, 2006

Study Completion

September 1, 2007

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

US(1)