Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?

WG
JK
Overseen ByJordan Kase, MD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Khang Nguyen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk of chronic lung disease associated with prematurity. Only babies who meet treatment criteria will receive this medication. Babies who do not meet treatment criteria will not receive medication.

The main questions it aims to answer are:

* Does betamethasone make it easier for babies to come off a breathing machine?

* Does betamethasone cause any harmful side effects on growth or development?

All babies in this study will:

* Receive standard NICU care, with or without betamethasone

* Have their progress, growth, and development followed over time

Who Is on the Research Team?

JK

Jordan Kase, MD

Principal Investigator

Maria Fareri Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

* Infants born at less than 28 weeks gestation age
* Admitted to WMC NICU prior to day of life 35

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Betamethasone armExperimental Treatment1 Intervention
Group II: ComparisonActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Khang Nguyen

Lead Sponsor