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Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Primary Purpose

Transient Tachypnea of the Newborn

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Experimental group: Budicort by Inhalation
placebo
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Tachypnea of the Newborn focused on measuring TTN

Eligibility Criteria

4 Hours - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bnai Zion Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled steroids (Budicort)

Control

Arm Description

Inhaled Budicort

Inhaled NS 0.9%

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 14, 2013
Last Updated
January 28, 2015
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01858129
Brief Title
Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn
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 Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea of the Newborn
Keywords
TTN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhaled steroids (Budicort)
Arm Type
Experimental
Arm Description
Inhaled Budicort
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Inhaled NS 0.9%
Intervention Type
Drug
Intervention Name(s)
Experimental group: Budicort by Inhalation
Intervention Description
Inhaled Budicort twice daily
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Assessment of respiratory distress
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 at 12, 24 and 48 hours after the first dose of inhaled study medication.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
The secondary outcome will be the assessment of morbidity associated with TTN
Description
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.
Time Frame
An average time period expected to be 5 days, according to the duration of hospital stay
Other Pre-specified Outcome Measures:
Title
Will follow blood pressure
Description
Blood pressure measurements
Time Frame
An average time period expected to be 5 days, according to the duration of hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Hours
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Kugelman, MD
Email
amirkug@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
David Bader, MD
Email
davidbade@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Kugelman, MD
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Kugelman, MD
Phone
972-4-8359559
Email
amirkug@gmail.com
First Name & Middle Initial & Last Name & Degree
David Bader, MD
Phone
972-4-8359559
Email
davidbade@gmail.com
First Name & Middle Initial & Last Name & Degree
David Bader, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28672098
Citation
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.
Results Reference
derived

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Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

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