Dexamethasone Therapy in VLBW Infants at Risk of CLD

Trial ID or NCT#

NCT00011362

Status

not recruiting iconNOT RECRUITING

Purpose

Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known. This trial looked at the benefits and hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in premature infants.

Official Title

Randomized Clinical Trial of Dexamethasone Therapy in Very-Low-Birth-Weight Infants at Risk for Chronic Lung Disease (CLD)

Eligibility Criteria

Ages Eligible for Study: 0 to 17
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 501 to 1500 grams* 13 to 15 days old* Respiratory-index score of greater than or equal to 2.4 that had been increasing or minimally decreasing during the previous 48 hours or a score of greater than or equal to 4.0 even if there had been improvement during the preceding 48 hours
Exclusion Criteria:
  1. * Received glucocorticoid treatment after birth* Had evidence or suspicious signs of sepsis as judged by the treating physician* Major congenital anomaly of the cardiovascular, pulmonary, or central nervous system

Investigator(s)

David K. Stevenson, M.D.