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

Primary Purpose

Transient Tachypnea of the Newborn

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Bubble Nasal CPAP
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Tachypnea of the Newborn focused on measuring transient tachypnea of the newborn, high flow nasal cannula, bubble nasal, continuous positive airway pressure

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Flow Nasal Cannula

Control Group- Bubble Nasal CPAP

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Duration of Respiratory Support
Data not collected due to insufficient enrollment for any data analysis.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2010
Last Updated
December 23, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT01270581
Brief Title
High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
Official Title
High Flow Nasal Cannula vs Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of sufficient enrollment
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea of the Newborn
Keywords
transient tachypnea of the newborn, high flow nasal cannula, bubble nasal, continuous positive airway pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group- Bubble Nasal CPAP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High Flow Nasal Cannula
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Bubble Nasal CPAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of Respiratory Support
Description
Data not collected due to insufficient enrollment for any data analysis.
Time Frame
average of 7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Weintraub, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19499590
Citation
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.
Results Reference
background
PubMed Identifier
18974751
Citation
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.
Results Reference
background
PubMed Identifier
18760803
Citation
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.
Results Reference
background
PubMed Identifier
8416477
Citation
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.
Results Reference
background
PubMed Identifier
17262040
Citation
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.
Results Reference
background
PubMed Identifier
11331690
Citation
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.
Results Reference
background

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

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