Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorKhang Nguyen
About this trial
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
Eligibility criteria
Qualifiers
Infants born at less than 28 weeks gestation age
Admitted to WMC NICU prior to day of life 35
Disqualifiers
Infants with major congenital or chromosomal abnormalities.
Death prior to DOL 8.
Previous exposure to postnatal steroids
Trial design
Treatments tested in this trial
- Betamethasone
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Khang Nguyen
Lead sponsor
New York Medical College
Sponsor institution
Source ClinicalTrials.gov