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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Betamethasone
DrugInfants 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Betamethasone armExperimental treatment 1 intervention
Group B: ComparisonNo intervention 0 interventions
Trial outcomes
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
Time frame
From initiation of treatment until 7 days after treatment completionSecondary outcomes
1
The incidence of adverse events
The incidence of hyperglycemia (\>150 mg/dL) during administration period
Time frame
During betamethasone administration period (5 days)2
The incidence of adverse events
The incidence of hypertension (requiring medication) anytime during hospitalization
Time frame
From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes first3
The incidence of adverse events
The incidence of gastrointestinal perforation (during or less than 72 hours after treatment completion)
Time frame
During betamethasone administration period and up to 72 hours after completion of betamethasone administration4
The incidence of adverse events
The incidence of culture-positive infection that requires treatment
Time frame
From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Khang Nguyen
Lead sponsor
New York Medical College
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: