Comparison of Humidified High Flow Nasal Cannula to Nasal CPAP in Neonates

NCT00609882 | Completed DMC

• 2 other identifiers: 24721UofU_IRB_00024721
• Study Type: interventional
• Target: 420
• Locations: 2 countries
• Sites: 9

Brief Summary

We hypothesize that the success rate for keeping babies extubated (without a breathing tube for assisted mechanical ventilation), defined as the proportion of infants remaining extubated for a minimum of 72 hours, will be equivalent among infants managed with nasal CPAP compared to humidified high flow nasal cannula (HHFNC).

Conditions

Respiratory Insufficiency

Keywords

Nasal CPAP; High flow nasal cannula; Neonate

Outcome Measures

Primary Outcomes (1)

• Compare extubation success rate, defined as % infants remaining extubated for > 72 hrs, among infants managed with HHFNC versus nCPAP

  72 hrs

Secondary Outcomes (4)

• Compare frequency of significant apnea after extubation to HHFNC v CPAP

  7 days

• Compare total duration of ventilator, positive pressure (CPAP and/or HHFNC), and oxygen use up to the time of discharge from the NICU

  3 months

• Compare incidence of potential adverse effects associated with the use of nasal CPAP and HHFNC including pulmonary air leaks, nasal deformities, feeding intolerance, necrotizing enterocolitis, intestinal perforation and BPD

  3 months

• Compare weight gain and the time to establish full enteral feeds (> 120 ml/kg/d) between infants on HHFNC v CPAP

  3 months

Study Arms (2)

HHFNC

ACTIVE COMPARATOR

Infants randomized to the Humidified High Flow Nasal Cannula (HHFNC) treatment group post extubation

Other: Nasal CPAP; Other: Humidified High Flow Nasal Cannula (HHFNC)

nCPAP

ACTIVE COMPARATOR

Infants randomized to the nasal Continuous Positive Airway Pressure (nCPAP) treatment group

Other: Nasal CPAP; Other: Humidified High Flow Nasal Cannula (HHFNC)

Interventions

Nasal CPAP OTHER

Infants randomized to the Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O post extubation

HHFNC; nCPAP

Humidified High Flow Nasal Cannula (HHFNC) OTHER

HHFNC

HHFNC; nCPAP

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight \> 1000 grams and \> 27 weeks gestation
• Candidate for non-invasive respiratory support as a result of:
• an intention to manage the infant with non-invasive (no endotracheal tube) respiratory support from birth initiated in the first 24 hours of life
• an intention to extubate an infant being managed with intubated respiratory support to non-invasive support

You may not qualify if:

• Birth weight \< 1000 grams
• Estimated gestation \< 29 weeks
• Participation in a concurrent study that prohibits the use of HHFNC
• Active air leak syndrome
• Infants with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis, cleft lip and/or palate, or
• Infants with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia.

Sponsors & Collaborators

• University of Utah: lead
• Intermountain Health Care, Inc.: collaborator

Study Sites (9)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

McKay-Dee Medical Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

University Hospital

Salt Lake City, Utah, 84132, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84157, United States

Location

Dixie Medical Center

St. George, Utah, 84770, United States

Location

Hebei Provincial Children's Hospital

Shijiazhuang, China

Location

Related Publications (11)

• Avery ME, Tooley WH, Keller JB, Hurd SS, Bryan MH, Cotton RB, Epstein MF, Fitzhardinge PM, Hansen CB, Hansen TN, et al. Is chronic lung disease in low birth weight infants preventable? A survey of eight centers. Pediatrics. 1987 Jan;79(1):26-30.

  PMID: 3797169 BACKGROUND

• Van Marter LJ, Allred EN, Pagano M, Sanocka U, Parad R, Moore M, Susser M, Paneth N, Leviton A. Do clinical markers of barotrauma and oxygen toxicity explain interhospital variation in rates of chronic lung disease? The Neonatology Committee for the Developmental Network. Pediatrics. 2000 Jun;105(6):1194-201. doi: 10.1542/peds.105.6.1194.

  PMID: 10835057 BACKGROUND

• Thomson MA, Yoder BA, Winter VT, Martin H, Catland D, Siler-Khodr TM, Coalson JJ. Treatment of immature baboons for 28 days with early nasal continuous positive airway pressure. Am J Respir Crit Care Med. 2004 May 1;169(9):1054-62. doi: 10.1164/rccm.200309-1276OC. Epub 2004 Feb 12.

  PMID: 14962819 BACKGROUND

• Woodhead DD, Lambert DK, Clark JM, Christensen RD. Comparing two methods of delivering high-flow gas therapy by nasal cannula following endotracheal extubation: a prospective, randomized, masked, crossover trial. J Perinatol. 2006 Aug;26(8):481-5. doi: 10.1038/sj.jp.7211543. Epub 2006 May 25.

  PMID: 16724119 BACKGROUND

• 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: 11331690 BACKGROUND

• Kopelman AE, Holbert D. Use of oxygen cannulas in extremely low birthweight infants is associated with mucosal trauma and bleeding, and possibly with coagulase-negative staphylococcal sepsis. J Perinatol. 2003 Mar;23(2):94-7. doi: 10.1038/sj.jp.7210865.

  PMID: 12673256 BACKGROUND

• Saslow JG, Aghai ZH, Nakhla TA, Hart JJ, Lawrysh R, Stahl GE, Pyon KH. Work of breathing using high-flow nasal cannula in preterm infants. J Perinatol. 2006 Aug;26(8):476-80. doi: 10.1038/sj.jp.7211530. Epub 2006 May 11.

  PMID: 16688202 BACKGROUND

• Kubicka ZJ, Limauro J, Darnall RA. Heated, humidified high-flow nasal cannula therapy: yet another way to deliver continuous positive airway pressure? Pediatrics. 2008 Jan;121(1):82-8. doi: 10.1542/peds.2007-0957.

  PMID: 18166560 BACKGROUND

• Shoemaker MT, Pierce MR, Yoder BA, DiGeronimo RJ. High flow nasal cannula versus nasal CPAP for neonatal respiratory disease: a retrospective study. J Perinatol. 2007 Feb;27(2):85-91. doi: 10.1038/sj.jp.7211647.

  PMID: 17262040 BACKGROUND

• Campbell DM, Shah PS, Shah V, Kelly EN. Nasal continuous positive airway pressure from high flow cannula versus Infant Flow for Preterm infants. J Perinatol. 2006 Sep;26(9):546-9. doi: 10.1038/sj.jp.7211561. Epub 2006 Jul 13.

  PMID: 16837929 BACKGROUND

• Yoder BA, Stoddard RA, Li M, King J, Dirnberger DR, Abbasi S. Heated, humidified high-flow nasal cannula versus nasal CPAP for respiratory support in neonates. Pediatrics. 2013 May;131(5):e1482-90. doi: 10.1542/peds.2012-2742. Epub 2013 Apr 22.

  PMID: 23610207 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Bradley A Yoder, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

US (8); CN (1)