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

NCT07447739 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 28646
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

respiratory distress syndrome; bronchopulmonary dysplasia; extremely low gestational age neonates; postnatal corticosteroids; betamethasone

Outcome Measures

Primary Outcomes (1)

• The rate of successful respiratory weaning

  * 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 Outcomes (10)

• The incidence of adverse events

  During betamethasone administration period (5 days)

• The incidence of adverse events

  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

  During betamethasone administration period and up to 72 hours after completion of betamethasone administration

• The incidence of adverse events

  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

  From admission until the time of NICU discharge or 52 weeks of age, whichever comes first

Study Arms (2)

Betamethasone arm

EXPERIMENTAL

Infants who meet clinical criteria will receive postnatal betamethasone

Drug: Betamethasone

Comparison

NO INTERVENTION

Infants who do not meet criteria to receive treatment

Interventions

Betamethasone DRUG

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

Betamethasone arm

Eligibility Criteria

• Age: Up to 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Khang Nguyen: lead

Study Sites (1)

Maria Fareri Children's Hospital at Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Related Publications (1)

• DeCastro M, El-Khoury N, Parton L, Ballabh P, LaGamma EF. Postnatal betamethasone vs dexamethasone in premature infants with bronchopulmonary dysplasia: a pilot study. J Perinatol. 2009 Apr;29(4):297-304. doi: 10.1038/jp.2008.194. Epub 2008 Dec 4.

  PMID: 19052552 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jordan Kase, MD

  Maria Fareri Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Kase, MD

CONTACT

914-493-8558; jordan.kase@wmchealth.org

Wendi Gu, MD

CONTACT

914-493-8558; wendi.gu@wmchealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Infants with lung diease severe enough according to predetermined criteria will receive betamethasone, and will be monitored for efficacy and side effects. Infants who do not meet criteria will not receive the drug and serve as comparison group.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 3, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)