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

Part of paid clinical trials in Valhalla, New York.

Sponsor
Khang Nguyen
Study ID
NCT07447739
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 28 Weeks
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Betamethasone arm
    Infants who meet clinical criteria will receive postnatal betamethasone
  • No Intervention: Comparison
    Infants who do not meet criteria to receive treatment

Primary Outcome Measure

The rate of successful respiratory weaning [ Time Frame: From initiation of treatment until 7 days after treatment completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maria Fareri Children's Hospital at Westchester Medical CenterValhallaNew York10595
Jordan Kase, MD
[email protected]
914-493-8558

Find similar trials in Valhalla, NY

By research site
Maria Fareri Children's Hospital at Westchester Medical Center· Valhalla, NY

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