Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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