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Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Bnai Zion Medical Center
Sponsor:
Information provided by (Responsible Party):
Kugelman Amir, Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01858129
First received: May 14, 2013
Last updated: January 28, 2015
Last verified: January 2015
History of Changes
  Purpose

Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.

The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.


Condition Intervention Phase
Transient Tachypnea of the Newborn
 Drug: Experimental group: Budicort by Inhalation
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn in Infants Born at >34 Weeks Gestation: A Prospective, Randomized, Double Blind, Placebo Controlled Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • Assessment of respiratory distress [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo at 12, 24 and 48 hours after the first dose of inhaled study medication.


Secondary Outcome Measures:
  • The secondary outcome will be the assessment of morbidity associated with TTN [ Time Frame: An average time period expected to be 5 days, according to the duration of hospital stay ] [ Designated as safety issue: No ]
    The secondary outcome will be the assessment of morbidity associated with TTN as reflected by time to spontaneous unsupported breathing of room air (hours), time to spontaneous breathing (LFNC and/or FiO2<0.3) for infants who got a higher level of respiratory support, maximal level of respiratory support (no oxygen, intra-incubator oxygen, LFNC, nCPAP, NIPPV, high flow nasal canulla, SIMV, HFOV), LOS (days), TFF (hours), need and length of antibiotic therapy in the study vs. placebo groups.


Other Outcome Measures:
  • Will follow blood pressure [ Time Frame: An average time period expected to be 5 days, according to the duration of hospital stay ] [ Designated as safety issue: Yes ]
    Blood pressure measurements
Estimated Enrollment: 56
Study Start Date: March 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled steroids (Budicort)
Inhaled Budicort
 Drug: Experimental group: Budicort by Inhalation
Inhaled Budicort twice daily
Placebo Comparator: Control
Inhaled NS 0.9%
 Drug: placebo

Detailed Description:

The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo.

  Eligibility
Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by cesarean section or vaginal delivery
  • Diagnosis of TTN
  • Parents signed informed consent

Exclusion Criteria:

  • Meconium aspiration syndrome
  • Respiratory distress syndrome
  • Congenital heart disease
  • Non respiratory disorders causing tachypnea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858129

Contacts
Contact: Amir Kugelman, MD amirkug@gmail.com
Contact: David Bader, MD davidbade@gmail.com

Locations
Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Amir Kugelman, MD    972-4-8359559    amirkug@gmail.com   
Contact: David Bader, MD    972-4-8359559    davidbade@gmail.com   
Sub-Investigator: David Bader, MD         
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Amir Kugelman, MD Bnai Zion Medical Center
  More Information

No publications provided

Responsible Party: Kugelman Amir, Head, Pediatric Pulmonary Unit, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01858129     History of Changes
Other Study ID Numbers: 0090-11-BNZ
Study First Received: May 14, 2013
Last Updated: January 28, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Bnai Zion Medical Center:
TTN

Additional relevant MeSH terms:
Tachypnea
Transient Tachypnea of the Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
 Respiration Disorders
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on March 03, 2015