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

NCT07447739 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-03

No results posted yet for this study

Summary

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

Conditions

  • Respiratory Distress Syndrome (RDS)
  • Bronchopulmonary Dysplasia (BPD)

Interventions

DRUG

Betamethasone

Infants who meet clinical criteria will receive a 5-day course of postnatal betamethasone: 0.125 mg/kg/dose IM every 24 hours for 3 days then 0.0625 mg/kg/dose IM every 24 hours for 2 days

Sponsors & Collaborators

  • Khang Nguyen

    lead OTHER

Principal Investigators

  • Jordan Kase, MD · Maria Fareri Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07447739 on ClinicalTrials.gov