Dexamethasone Therapy in VLBW Infants at Risk of CLD

• Status: Completed
• Trial end date: 1994-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion criteria:

• 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:

• 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