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NCT Number: NCT07447739

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

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

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Key information

Conditions

Respiratory Distress Syndrome (RDS) Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia (BPD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

Up to 28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maria Fareri Children's Hospital at Westchester Medical Center

Valhalla, New York, 10595, United States

Location contact

Jordan Kase, MD

CONTACT

[email protected]

914-493-8558

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. The incidence of adverse events

    Time frame: During betamethasone administration period (5 days)

    The incidence of hyperglycemia (>150 mg/dL) during administration period

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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)

  9. 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.

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Kase, MD

CONTACT

[email protected]

914-493-8558

Wendi Gu, MD

CONTACT

[email protected]

914-493-8558

Sponsors and collaborators

Lead sponsor

Khang Nguyen

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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