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Late Low-Dose Dexamethasone in Preterm Neonates Using DART Protocol
Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Summary
Premature babies, especially those who need breathing support for many days, are at risk of developing a long-term lung condition called bronchopulmonary dysplasia (BPD). BPD usually means that the baby still needs oxygen or breathing support around 36 weeks' postmenstrual age. This condition can make recovery longer and may affect the baby's breathing and development later in life. This study looked at whether a low dose of dexamethasone, a steroid medicine that reduces inflammation, could help premature babies who were still dependent on a ventilator or non-invasive breathing support after the first week of life. The medicine was given using the DART protocol, which is a short, low-dose course of dexamethasone designed to help babies come off breathing support while reducing the risk of side effects. The study was conducted in the Neonatal Intensive Care Unit (NICU) at the Children's Hospital, Pakistan Institute of Medical Sciences (PIMS), Islamabad. A total of 93 premature babies were included. All babies were more than 7 days old, born between 28 and 36 weeks of pregnancy, weighed less than 2000 grams at birth, and still needed significant breathing support. Babies with certain serious conditions, such as major congenital abnormalities, severe intestinal disease, or previous steroid exposure, were not included. Investigators recorded each baby's oxygen requirement and ventilator pressure before and during dexamethasone treatment. They also observed whether the baby could be successfully removed from the ventilator within 10 days, how long oxygen and breathing support were needed, and whether any side effects occurred. After treatment, babies needed less oxygen and lower ventilator pressure. The oxygen requirement decreased from 0.56 to 0.33, and mean airway pressure decreased from 12.3 to 8.9 cmH₂O. Seventy out of 93 babies, or 75.3%, were successfully extubated within 10 days. At 36 weeks' postmenstrual age, 26.9% of babies met the criteria for BPD. The short-term side effects were manageable. Eleven babies developed temporary high blood sugar, and six developed high blood pressure; both were treated medically. No gastrointestinal perforation or steroid-related death was observed. This study suggests that late, low-dose dexamethasone may help selected premature babies reduce breathing support and come off the ventilator earlier. However, because this was a single-arm study without a comparison group, it cannot prove that dexamethasone prevents BPD. Larger controlled studies with long-term follow-up are needed to confirm the benefits and safety of this treatment.
Official title: Effect of Late (>7 Days) Low-Dose Dexamethasone on Ventilated Preterm Neonates to Prevent Bronchopulmonary Dysplasia: A Quasi-experimental Study
Key Details
Gender
All
Age Range
8 Days - Any
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2025-06-18
Completion Date
2025-11-15
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone
Systemic dexamethasone was administered parenterally according to the DART protocol: 0.075 mg/kg per dose every 12 hours on days 1-3, 0.05 mg/kg per dose every 12 hours on days 4-6, 0.025 mg/kg per dose every 12 hours on days 7-8, and 0.01 mg/kg per dose every 12 hours on days 9-10. The planned cumulative dose was 0.89 mg/kg over 10 days. Treatment was discontinued if pulmonary haemorrhage or newly detected or worsening intraventricular haemorrhage occurred.
Locations (1)
Children's Hospital, Pakistan Institute of Medical Sciences
Islamabad, Islamabad, Pakistan