Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

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.

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.

Study Overview

• Status: Unknown
• Conditions: Transient Tachypnea of the Newborn
• Intervention / Treatment: Drug: placebo; Drug: Experimental group: Budicort by Inhalation

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
• Enrollment (Anticipated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amir Kugelman, MD; Email: amirkug@gmail.com
• Study Contact Backup: Name: David Bader, MD; Email: davidbade@gmail.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Bnai Zion Medical Center
    • Contact: Amir Kugelman, MD; Phone Number: 972-4-8359559; Email: amirkug@gmail.com
    • Contact: David Bader, MD; Phone Number: 972-4-8359559; Email: davidbade@gmail.com
    • Sub-Investigator: David Bader, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 hours to 6 hours (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of respiratory distress	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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome will be the assessment of morbidity associated with TTN	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.	An average time period expected to be 5 days, according to the duration of hospital stay

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Will follow blood pressure	Blood pressure measurements	An average time period expected to be 5 days, according to the duration of hospital stay

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Publications and helpful links

General Publications

• Vaisbourd Y, Abu-Raya B, Zangen S, Arnon S, Riskin A, Shoris I, Elias N, Bader D, Kugelman A. Inhaled corticosteroids in transient tachypnea of the newborn: A randomized, placebo-controlled study. Pediatr Pulmonol. 2017 Aug;52(8):1043-1050. doi: 10.1002/ppul.23756. Epub 2017 Jul 3.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): May 1, 2015

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (ESTIMATE): May 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 29, 2015
• Last Update Submitted That Met QC Criteria: January 28, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: TTN
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Tachypnea; Transient Tachypnea of the Newborn
• Other Study ID Numbers: 0090-11-BNZ