Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome (RDS)
Conditions
Keywords
respiratory distress syndrome, bronchopulmonary dysplasia, extremely low gestational age neonates, postnatal corticosteroids, betamethasone
Brief 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. 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.
Interventions
DRUGBetamethasone
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
Sponsors
Khang Nguyen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of successful respiratory weaning | 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
| Measure | Time frame | Description |
|---|---|---|
| The incidence of adverse events | During betamethasone administration period (5 days) | The incidence of hyperglycemia (\>150 mg/dL) during administration period |
| The incidence of mortbidities associated with extreme prematurity | 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 |
| Anthropometric measurements | 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) |
| Neurodevelopmental outcomes | 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. |
| Bronchopulmonary dysplasia diagnosis | 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 |
Countries
United States
Contacts
CONTACTJordan Kase, MD
CONTACTWendi Gu, MD
PRINCIPAL_INVESTIGATORJordan Kase, MD
Maria Fareri Children's Hospital
Outcome results
None listed