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

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

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).

Study Overview

• Status: Terminated
• Conditions: Transient Tachypnea of the Newborn
• Intervention / Treatment: Other: High Flow Nasal Cannula; Other: Bubble Nasal CPAP

Detailed Description

Transient Tachypnea of the Newborn, fetal lung fluid retention causing poor lung compliance and atelectasis, is a common entity in neonates ≥ 36 weeks in our unit. Currently our standard of care includes using the respiratory modality of bubble nasal continuous positive airway pressure (BNCPAP) to support these neonates during this illness. BNCPAP provides positive distending pressure to recruit alveoli and prevent atelectasis, however, it is associated with air leak (pneumothorax, pneumomediastinum), nasal irritation and necrosis, and intolerance. HFNC is another respiratory modality that uses high flow gas that also provides positive distending pressure and thus prevents atelectasis. This modality does not cause nasal irritation or necrosis and has a minimal risk of air leak. We postulate that HFNC is a superior modality to BNCPAP in treating neonates ≥ 36 weeks with TTN. This will be determined by comparing the duration of respiratory support (in hours) for newborns ≥ 36 weeks gestation with a diagnosis to TTN randomized to receive either NCPAP or HFNC for respiratory care.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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: High Flow Nasal Cannula; 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; 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.
Active Comparator: Control Group- Bubble Nasal CPAP; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Respiratory Support	Data not collected due to insufficient enrollment for any data analysis.	average of 7 days

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Andrea Weintraub, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 21, 2010
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: December 23, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: high flow nasal cannula; continuous positive airway pressure; transient tachypnea of the newborn; bubble nasal
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Tachypnea; Transient Tachypnea of the Newborn
• Other Study ID Numbers: 10-0603 (Portland VAMC R&D)