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Clinical Trials/ACTRN12608000295347
ACTRN12608000295347
Completed
未知

Response of premature infants born before 29 weeks gestation to early targeted treatment with indomethacin vs placebo in terms of the combined outcome of mortality/abnormal head ultrasound at nursery discharge.

Martin Kluckow0 sites370 target enrollmentJune 13, 2008
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Martin Kluckow
Enrollment
370
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 13, 2008
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Martin Kluckow

Eligibility Criteria

Inclusion Criteria

  • •Infants born \< 29 weeks gestational age
  • •Infants \< 12 hours old
  • •Echocardiogram to assess ductal size able to be performed

Exclusion Criteria

  • •1] Intraventricular haemorrhage grade 3 – 4 at time of initial scan.
  • •2] Baby is clinically unstable and not expected to survive.
  • •3] Congenital anomalies predicted to influence neurodevelopmental outcome
  • •4] Structural heart disease
  • •5] R\-\>L shunt \- infants with near systemic or suprasystemic pulmonary pressure who may benefit from some RV pressure relief – R\>L ductal flow for \>33% of cardiac cycle. Rescan in same 12 hour time frame.
  • •6] Contraindication to use of indomethacin or ibuprofen (Platelet count \<50,000, Creatinine \>120 micromol/L, use of NSAID antenatally)
  • •7] Unlikely to be able to commence first dose of treatment by 12 hours of age
  • •8] Consent not given

Outcomes

Primary Outcomes

Not specified

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