Betamethasone for Breathing Support in Premature Babies

WG
JK
Overseen ByJordan Kase, MD
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?

This trial explores whether betamethasone, a steroid, can help extremely premature babies (born before 28 weeks) breathe easier and reduce the risk of long-term lung problems. The trial will assess if this medication enables babies to come off breathing machines safely without affecting growth or development. Babies in the study will receive standard NICU care, with only some receiving betamethasone based on specific treatment criteria. Families with babies born before 28 weeks and admitted to a participating NICU may consider this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I have to stop my baby's current medications for this trial?

The trial information does not specify whether you need to stop your baby's current medications. It mentions that all babies will receive standard NICU care, which usually includes continuing necessary medications.

Is there any evidence suggesting that betamethasone is likely to be safe for premature babies?

Research has shown that betamethasone can aid in the lung development of preterm babies before birth. Studies indicate that babies receiving this steroid often require less breathing assistance after birth. However, some risks exist. For instance, certain studies found that babies exposed to betamethasone might experience low blood sugar after birth, a condition known as neonatal hypoglycemia. Doctors monitor this closely. Overall, betamethasone is usually well-tolerated, but weighing the potential benefits and risks is important.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breathing support in premature babies, which usually involve mechanical ventilation or surfactant therapy, betamethasone works by reducing inflammation in the lungs. This steroid can potentially enhance lung function and decrease the need for invasive breathing support. Researchers are excited about betamethasone because it could offer a less invasive option, minimizing potential complications associated with other treatments. Additionally, its anti-inflammatory properties may improve overall outcomes for these vulnerable infants.

What evidence suggests that betamethasone might be an effective treatment for breathing support in premature babies?

Studies have shown that betamethasone can greatly help extremely premature babies breathe better. Research indicates that it lowers the risk of chronic lung disease, common in these infants. In this trial, infants meeting clinical criteria will receive postnatal betamethasone. One study found that babies who received betamethasone were less likely to need breathing support soon after birth. Another study showed a 33% decrease in serious breathing problems with this steroid. Overall, betamethasone seems to support lung development, making it easier for babies to breathe independently.26789

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?

This trial is for babies born before 28 weeks of pregnancy who are in the NICU at WMC within their first month. Babies with major birth defects, genetic conditions, those who passed away before day 8, or who already received steroids after birth cannot join.

Inclusion Criteria

I was born before 28 weeks of pregnancy.
Admitted to WMC NICU prior to day of life 35

Exclusion Criteria

Infants with major congenital or chromosomal abnormalities
Death prior to day of life 8
Previous exposure to postnatal steroids

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants who meet clinical criteria will receive postnatal betamethasone to aid in respiratory weaning

7 days
Continuous monitoring in NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including growth and development assessments

From discharge to 24 months corrected age
Regular assessments until 24 months corrected age

Long-term follow-up

Monitoring of neurodevelopmental outcomes and other morbidities associated with extreme prematurity

Up to 52 weeks of age or NICU discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Betamethasone

Trial Overview

The study tests if giving betamethasone (a steroid) to extremely premature babies helps them come off breathing machines more safely and reduces lung problems. Some babies will get betamethasone plus standard care; others will get only standard care.

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

Citations

A Comparative Study of the Respiratory Neonatal Outcomes ...

The number of neonates developed chronic lung disease has been remarkably reduced when using DSP in extremely (P = 0.038) and very (P = 0.046) ...

The effects of betamethasone on clinical outcome of the late ...

The use of betamethasone in the late preterm period (after 34 weeks of gestation) has no beneficial effects on lung maturity or preventing neonatal adverse ...

Evaluation of Long-term Outcomes Associated With ...

Exposure to a single course of antenatal corticosteroids was associated with a significant decrease in the adjusted odds of neurodevelopmental impairment in ...

Low-dose antenatal betamethasone treatment achieves ...

Obstetrics. Low-dose antenatal betamethasone treatment achieves preterm lung maturation equivalent to that of the World Health Organization dexamethasone ...

Betamethasone improves respiratory outcomes in late ...

The steroid was also associated with a 33% reduction in the risk of severe respiratory complications, Dr. Cynthia Gyamfi-Bannerman reported at ...

Antenatal steroids: benefits, risks, and new insights in

The ALPS trial found that babies exposed to betamethasone were significantly more likely to have neonatal hypoglycemia (glucose < 40 mg/dL) than ...

Antenatal Betamethasone for Women at Risk for Late ...

The primary outcome occurred in 165 of 1427 infants (11.6%) in the betamethasone group and 202 of 1400 (14.4%) in the placebo group (relative ...

Antenatal Corticosteroid Therapy for Fetal Maturation

Recent data also suggest that betamethasone can be beneficial in pregnant women at high risk of late preterm birth, between 34 0/7 weeks and 36 6/7 weeks of ...

Effects of single course and multicourse betamethasone prior ...

The aim of this study was to compare the prenatal administration of single and multiple courses of betamethasone and neonatal outcomes, effectiveness and safety