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

February 26, 2026 updated by: Khang Nguyen

Efficacy and Safety of Postnatal Betamethasone for Respiratory Weaning in Extremely Low Gestational Age Neonates (ELGANs) in a Prospective Cohort - Proof of Concept Pilot Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Babies born extremely early (before 28 weeks of pregnancy) often have very immature lungs and usually need a breathing machine to stay alive. Many of these babies develop a chronic lung disease associated with prematurity called bronchopulmonary dysplasia, which can cause breathing problems that may last for months or years.

Doctors sometimes use steroid medications after birth to help reduce lung inflammation, make breathing easier, and help babies come off the ventilator sooner. One of these medications is betamethasone. Betamethasone is already commonly given to mothers before preterm birth to help babies' lungs mature.

At our hospital, betamethasone has been given after birth for more than 20 years to help some premature babies breathe better and come off a breathing machine. This study will help us learn how well this medicine works and possible side effects.

All babies born before 28 weeks gestation will be approached for enrollment in this study. Babies with lung disease severe enough according to predetermined criteria will receive betamethasone. Babies who dont have severe lung disease will not receive betamethasone.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Valhalla, New York, United States, 10595
        • Maria Fareri Children's Hospital at Westchester Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants with major congenital or chromosomal abnormalities.
  • Death prior to DOL 8.
  • Previous exposure to postnatal steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Betamethasone arm
Infants who meet clinical criteria will receive postnatal betamethasone
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
No Intervention: Comparison
Infants who do not meet criteria to receive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of successful respiratory weaning
Time Frame: From initiation of treatment until 7 days after treatment completion
  • Defined by a 20% reduction from baseline in mean airway pressure or FiO2 if patient remains intubated
  • or successful extubation and maintenance of extubation for 7 days after betamethasone completion
From initiation of treatment until 7 days after treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse events
Time Frame: During betamethasone administration period (5 days)
The incidence of hyperglycemia (>150 mg/dL) during administration period
During betamethasone administration period (5 days)
The incidence of adverse events
Time Frame: From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes first
The incidence of hypertension (requiring medication) anytime during hospitalization
From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes first
The incidence of adverse events
Time Frame: During betamethasone administration period and up to 72 hours after completion of betamethasone administration
The incidence of gastrointestinal perforation (during or less than 72 hours after treatment completion)
During betamethasone administration period and up to 72 hours after completion of betamethasone administration
The incidence of adverse events
Time Frame: From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes first
The incidence of culture-positive infection that requires treatment
From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes first
The incidence of mortbidities associated with extreme prematurity
Time Frame: From admission until the time of NICU discharge or 52 weeks of age, whichever comes first

The incidence of

  • Severe intraventricular hemorrhage
  • Periventricular leukomalacia
  • Retinopathy of prematurity
  • Hemodynamically signifcant patent ductus arteriosus
From admission until the time of NICU discharge or 52 weeks of age, whichever comes first
Anthropometric measurements
Time Frame: From discharge to 24 months corrected age
weight at the time of discharge (in grams and percentile rank using Fenton growth curve 2013 for gestational age) and at 24 months corrected age (in grams and their corresponding percentile rank for age using CDC growth chart 0-36 months)
From discharge to 24 months corrected age
Anthropometric measurements
Time Frame: From discharge to 24 months corrected age
length at the time of discharge (in centimeters and percentile rank using Fenton growth curve 2013 for gestational age) and at 24 months corrected age (in centimeters and their corresponding percentile rank for age using CDC growth chart 0-36 months)
From discharge to 24 months corrected age
Anthropometric measurements
Time Frame: From discharge to 24 months corrected age
Head circumference at the time of discharge (in centimeters and percentile rank using Fenton growth curve 2013 for gestational age) and at 24 months corrected age (in centimeters and their corresponding percentile rank for age using CDC growth chart 0-36 months)
From discharge to 24 months corrected age
Neurodevelopmental outcomes
Time Frame: at 24 months corrected age
the results of evaluation utilizing the Bayley Scales of Infant Development. The minimum score is 40 and the maximun score is 160, with a higher score represents better outcome. The score of 100 is average, and 15 points represents 1 standard deviation either way.
at 24 months corrected age
Bronchopulmonary dysplasia diagnosis
Time Frame: at 36 weeks corrected age

Using the 2019 Jensen criteria:

  • Grade 1 - nasal cannula ≤2 L/min
  • Grade 2 - nasal cannula >2 L/min or noninvasive positive airway pressure
  • Grade 3 - invasive mechanical ventilation
at 36 weeks corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khang Nguyen

Investigators

  • Principal Investigator: Jordan Kase, MD, Maria Fareri Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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