High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation

NCT01270581 | Terminated Results DMC

• 1 other identifier: 10-0603
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN) when compared to the standard of care modality (NCPAP).

Conditions

Transient Tachypnea of the Newborn

Keywords

transient tachypnea of the newborn; high flow nasal cannula; bubble nasal; continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Duration of Respiratory Support

  Data not collected due to insufficient enrollment for any data analysis.

  average of 7 days

Study Arms (2)

High Flow Nasal Cannula

EXPERIMENTAL

Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).

Other: High Flow Nasal Cannula

Control Group- Bubble Nasal CPAP

ACTIVE COMPARATOR

NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.

Other: Bubble Nasal CPAP

Interventions

High Flow Nasal Cannula OTHER

Humidified high flow nasal cannula (HFNC) has emerged as an alternative respiratory modality for late preterm newborns with respiratory distress. Like NCPAP, oxygen is delivered to the infant via nasal prongs and provides a continuous distending pressure. Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7.

High Flow Nasal Cannula

Bubble Nasal CPAP OTHER

NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.

Control Group- Bubble Nasal CPAP

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• gestational age ≥ 35 weeks
• diagnosis of TTN, defined as respiratory rate \>60, presence of subcostal and /or intercostal retractions, nasal flaring, grunting, oxygen saturations 70-93% on room air, and radiological evidence of perihilar streaking and patchy infiltrates
• admission to the NICU at Mount Sinai hospital within first 24 hours of life

You may not qualify if:

• gestational age \< 35 weeks
• history of thick meconium stained fluid and/or diagnosis of meconium aspiration syndrome
• diagnosis of major congenital pulmonary or cardiac anomalies
• initial CXR demonstrating air leak
• respiratory distress first occurring after 24 hours of life
• presumptive diagnosis of RDS as indicated by the need for FiO2 \> 40%, severe retractions and grunting with poor air entry, and diffuse alveolar consolidation on chest radiograph

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (6)

• Dani C, Pratesi S, Migliori C, Bertini G. High flow nasal cannula therapy as respiratory support in the preterm infant. Pediatr Pulmonol. 2009 Jul;44(7):629-34. doi: 10.1002/ppul.21051.

  PMID: 19499590 BACKGROUND

• Jasin LR, Kern S, Thompson S, Walter C, Rone JM, Yohannan MD. Subcutaneous scalp emphysema, pneumo-orbitis and pneumocephalus in a neonate on high humidity high flow nasal cannula. J Perinatol. 2008 Nov;28(11):779-81. doi: 10.1038/jp.2008.99.

  PMID: 18974751 BACKGROUND

• 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: 18760803 BACKGROUND

• 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: 8416477 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

• 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

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

low enrollment, data not analyzed - too small for any meaningful interpretation

Results Point of Contact

• Title: Dr. Andrea Weintraub
• Organization: Mount Sinai School of Medicine

andrea.weintraub@mssm.edu

212-241-6186

Study Officials

• Andrea Weintraub, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: January 5, 2011
• Study Start: July 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 16, 2017
• Results First Posted: February 16, 2017

Record last verified: 2016-12

Locations

US (1)