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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:
All babies in this study will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betamethasone arm | Experimental | Infants who meet clinical criteria will receive postnatal betamethasone |
|
| Comparison | No Intervention | Infants who do not meet criteria to receive treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of successful respiratory weaning |
| From initiation of treatment until 7 days after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events | The incidence of hyperglycemia (>150 mg/dL) during administration period | During betamethasone administration period (5 days) |
| The incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan Kase, MD | Contact | 914-493-8558 | jordan.kase@wmchealth.org | |
| Wendi Gu, MD | Contact | 914-493-8558 | wendi.gu@wmchealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Jordan Kase, MD | Maria Fareri Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Fareri Children's Hospital at Westchester Medical Center | Valhalla | New York | 10595 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19052552 | Background | 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. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055397 | Ventilator-Induced Lung Injury |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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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.
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The incidence of hypertension (requiring medication) anytime during hospitalization
| 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) | 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 | 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
| 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) | 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) | 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) | 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. | at 24 months corrected age |
| Bronchopulmonary dysplasia diagnosis | Using the 2019 Jensen criteria:
| at 36 weeks corrected age |
| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |