Single-dose Prophylactic INdomethacin in Extremely Preterm Infants

Launched by UNIVERSITY OF BRITISH COLUMBIA · Aug 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a single dose of a medication called indomethacin can help prevent serious brain bleeding in extremely premature infants, those born before 26 weeks of pregnancy. In Canada, around 900 of these tiny babies are born each year, and they face high risks of severe complications, including bleeding in the brain. Indomethacin is known to reduce this risk, but it is usually given in three doses, which can have side effects and may not always improve long-term brain development. Researchers believe that a single low dose might be just as effective and safer.

To find out if this single-dose approach works, the study will involve about 500 babies born very early, weighing less than 750 grams. These babies will be randomly assigned to receive either the indomethacin or a harmless placebo (a saline solution that looks the same) within 12 hours after birth. The doctors and researchers won't know which babies receive the medication and which receive the placebo, ensuring that the results are fair and unbiased. This trial is important because it aims to discover the safest and most effective way to protect these vulnerable infants from severe brain bleeding while improving their chances for survival. Families with babies born under these conditions may be eligible to participate, though certain medical conditions may exclude some infants from the study.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Extremely preterm infants born \<26 completed weeks of GA and/or extremely low BW infants born \<750g
• Exclusion Criteria:
• • antenatal diagnosis of duct dependent CHD
• • acute hypoxic respiratory failure \[defined as fraction of inspired oxygen (FiO2)\>0.60 for ≥2h)
• • inhaled nitric oxide (iNO) therapy due to suspected or confirmed acute pulmonary hypertension (PH)
• • receipt of prophylactic or therapeutic hydrocortisone
• • antenatal diagnosis of renal anomalies
• • initial platelet count \<50x109/L
• • decision to withhold/withdraw life-sustaining treatments