Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

NCT ID: NCT01858129

Last Updated: 2015-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transient Tachypnea of the Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inhaled steroids (Budicort)

Inhaled Budicort

Group Type EXPERIMENTAL

Experimental group: Budicort by Inhalation

Intervention Type DRUG

Inhaled Budicort twice daily

Control

Inhaled NS 0.9%

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental group: Budicort by Inhalation

Inhaled Budicort twice daily

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Hours

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kugelman Amir

Head, Pediatric Pulmonary Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amir Kugelman, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bnai Zion Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amir Kugelman, MD

Role: CONTACT

David Bader, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Amir Kugelman, MD

Role: primary

972-4-8359559

David Bader, MD

Role: backup

972-4-8359559

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28672098 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0090-11-BNZ

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Role of Salbutamol and Furosemide in TTN
NCT03208894 COMPLETED PHASE3