Respiratory Distress Syndrome (RDS)Phase 2NCT07447739
Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?
A Phase 2 study testing Betamethasone in people with Respiratory Distress Syndrome (RDS) and Bronchopulmonary Dysplasia (BPD), run by Khang Nguyen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 weeks
- Conditions the study is for
- Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD)
- What is being tested?
- Betamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at less than 28 weeks gestation age
- Admitted to WMC NICU prior to day of life 35
Who cannot join
- Infants with major congenital or chromosomal abnormalities.
- Death prior to DOL 8.
- Previous exposure to postnatal steroids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla, New York, 10595
Jordan Kase, MD, 914-493-8558, jordan.kase@wmchealth.org
About this study
Official 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
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:
Read more
- 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
Read the 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.
- Being tested
- Betamethasone
- Keywords
- respiratory distress syndrome, bronchopulmonary dysplasia, extremely low gestational age neonates, postnatal corticosteroids, betamethasone
- Medical subject headings
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
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 group | Role | What they receive |
|---|---|---|
| Betamethasone arm | Experimental | Infants who meet clinical criteria will receive postnatal betamethasone Receives: Drug: Betamethasone |
| Comparison | No intervention | Infants who do not meet criteria to receive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From initiation of treatment until 7 days after treatment completion
Secondary outcomes (10)
The incidence of adverse events
The incidence of hyperglycemia (>150 mg/dL) during administration period
Measured: During betamethasone administration period (5 days)
The incidence of adverse events
The incidence of hypertension (requiring medication) anytime during hospitalization
Measured: 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
The incidence of gastrointestinal perforation (during or less than 72 hours after treatment completion)
Measured: During betamethasone administration period and up to 72 hours after completion of betamethasone administration
The incidence of adverse events
The incidence of culture-positive infection that requires treatment
Measured: 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
The incidence of
- Severe intraventricular hemorrhage
- Periventricular leukomalacia
- Retinopathy of prematurity
- Hemodynamically signifcant patent ductus arteriosus
Measured: From admission until the time of NICU discharge or 52 weeks of age, whichever comes first
Anthropometric measurements
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)
Measured: From discharge to 24 months corrected age
Anthropometric measurements
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)
Measured: From discharge to 24 months corrected age
Anthropometric measurements
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)
Measured: From discharge to 24 months corrected age
Neurodevelopmental outcomes
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.
Measured: at 24 months corrected age
Bronchopulmonary dysplasia diagnosis
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
Measured: at 36 weeks corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome (RDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khang Nguyen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khang Nguyen, New York Medical College
- Investigators
- Jordan Kase, MD, Principal investigator, Maria Fareri Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447739
- Sponsor's protocol ID
- 28646
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19052552
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07447739
- Acronym / sponsor ID
- 28646
- Keywords
- respiratory distress syndrome, bronchopulmonary dysplasia, extremely low gestational age neonates, postnatal corticosteroids, betamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Khang NguyenUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Betamethasone arm | Experimental | Drug: BetamethasoneInfants who meet clinical criteria will receive postnatal betamethasone |
| Comparison | No intervention | –Infants who do not meet criteria to receive treatment |
Who may qualify
- Ages
- Up to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born at less than 28 weeks gestation age
- Admitted to WMC NICU prior to day of life 35
Key exclusion criteria (3 listed)
- Infants with major congenital or chromosomal abnormalities.
- Death prior to DOL 8.
- Previous exposure to postnatal steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetamethasoneInfants 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 | Drug | Betamethasone arm |
Primary outcome
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
10 secondary outcomes
The incidence of adverse events
Time frame: 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 adverse events
Time frame: 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 mortbidities associated with extreme prematurity
Time frame: 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
Anthropometric measurements
Time frame: From discharge to 24 months corrected age
Anthropometric measurements
Time frame: From discharge to 24 months corrected age
Neurodevelopmental outcomes
Time frame: at 24 months corrected age
Bronchopulmonary dysplasia diagnosis
Time frame: at 36 weeks corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 19052552DeCastro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordan Kase, MD principal investigator
Maria Fareri Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betamethasone in people with Respiratory Distress Syndrome (RDS) and Bronchopulmonary Dysplasia (BPD), run by Khang Nguyen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Kase, MD (914-493-8558, jordan.kase@wmchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful respiratory weaning (time frame: From initiation of treatment until 7 days after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.