Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Betamethasone.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD). Basic parameters: up to 28 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Postnatal Betamethasone for Respiratory Weaning in Extremely Low Gestational Age Neonates (ELGANs) in a Prospective Cohort - Proof of Concept Pilot Study
Overview
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
- Drug Betamethasone
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
Primary outcome measures
- The rate of successful respiratory weaning [Time frame: From initiation of treatment until 7 days after treatment completion]
Secondary outcome measures (10)
- The incidence of adverse events [Time frame: During betamethasone administration period (5 days)]
- The incidence of adverse events [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 [Time frame: During betamethasone administration period and up to 72 hours after completion of betamethasone administration]
- The incidence of adverse events [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 [Time frame: From admission until the time of NICU discharge or 52 weeks of age, whichever comes first]
- Anthropometric measurements [Time frame: From discharge to 24 months corrected age]
- Anthropometric measurements [Time frame: From discharge to 24 months corrected age]
- Anthropometric measurements [Time frame: From discharge to 24 months corrected age]
- Neurodevelopmental outcomes [Time frame: at 24 months corrected age]
- Bronchopulmonary dysplasia diagnosis [Time frame: at 36 weeks corrected age]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Maria Fareri Children's Hospital at Westchester Medical Center — Valhalla
Publications
- 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. PMID 19052552
Identifiers
NCT: NCT07447739 · 28646