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Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

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ClinicalTrials.gov Identifier: NCT01858129
Recruitment Status : Unknown
Verified January 2015 by Kugelman Amir, Bnai Zion Medical Center.
Recruitment status was:  Recruiting
First Posted : May 21, 2013
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Kugelman Amir, Bnai Zion Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Transient Tachypnea of the Newborn Drug: Experimental group: Budicort by Inhalation Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : March 2012
Estimated Primary Completion Date : May 2015


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Assessment of respiratory distress [ Time Frame: 48 hours ]
    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 :
  1. 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 ]
    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:
  1. Will follow blood pressure [ Time Frame: An average time period expected to be 5 days, according to the duration of hospital stay ]
    Blood pressure measurements



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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015

Keywords provided by Kugelman Amir, Bnai Zion Medical Center:
TTN

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