Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(lack of sufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01270581
First received: December 21, 2010
Last updated: December 23, 2016
Last verified: December 2016
Results First Received: December 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Transient Tachypnea of the Newborn
Interventions: Other: High Flow Nasal Cannula
Other: Bubble Nasal CPAP

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The NICU fellow on service, or on call, will identify all NICU admission that are potentially eligible for participation. Parents of potentially eligible subjects will be approached by a member of the NICU team to discuss study participation within 4 hours of admission to the NICU.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).
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.

Participant Flow:   Overall Study
    High Flow Nasal Cannula   Control Group- Bubble Nasal CPAP
STARTED   4   3 
COMPLETED   3   3 
NOT COMPLETED   1   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
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.
Total Total of all reporting groups

Baseline Measures
   High Flow Nasal Cannula   Control Group- Bubble Nasal CPAP   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   3   7 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      4 100.0%      3 100.0%      7 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
     
Female      3  75.0%      3 100.0%      6  85.7% 
Male      1  25.0%      0   0.0%      1  14.3% 


  Outcome Measures

1.  Primary:   Duration of Respiratory Support   [ Time Frame: average of 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
low enrollment, data not analyzed - too small for any meaningful interpretation


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Andrea Weintraub
Organization: Mount Sinai School of Medicine
phone: 212-241-6186
e-mail: andrea.weintraub@mssm.edu


Publications:

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01270581     History of Changes
Other Study ID Numbers: 10-0603
Study First Received: December 21, 2010
Results First Received: December 4, 2015
Last Updated: December 23, 2016