CompletedPhase 3

Dexamethasone Therapy in VLBW Infants at Risk of CLD

United States371 participantsStarted 1992-09

Plain-language 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.

Who can participate

Age range13 Days – 15 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of days from randomization to ventilator independence, defined as extubation not requiring reintubation, or extubation followed by elective reintubation for seven days or less so that the infant could undergo a surgical procedure

Timeframe: At hospital discharge

Trial details

NCT IDNCT00011362

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion1994-01

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