Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2015 by Kugelman Amir, Bnai Zion Medical Center.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01858129

First Posted: May 21, 2013

Last Update Posted: January 29, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Kugelman Amir, Bnai Zion Medical Center

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 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.

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Steroids

Genetic and Rare Diseases Information Center resources: Acute Respiratory Distress Syndrome Respiratory Distress Syndrome, Infant

U.S. FDA Resources

Further study details as provided by Kugelman Amir, Bnai Zion Medical Center:

Primary Outcome Measures:

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:

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:

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


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

Information from the National Library of Medicine

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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

Contacts and Locations

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

More Information


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 Submitted:	May 14, 2013
First Posted:	May 21, 2013
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

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