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
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla, New York, United States
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 completion
The incidence of adverse events
The incidence of hyperglycemia (\>150 mg/dL) during administration period
Time frame: During betamethasone administration period (5 days)
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 first
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 administration
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 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: at 36 weeks corrected age
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.