CompletedPhase 4ACTRN12605000492651

THE EFFECT OF PRETERM BIRTH ON OUTCOME - A RANDOMISED TRIAL OF PREVENTATIVE CARE

A RANDOMISED TRIAL OF PREVENTATIVE CARE AT HOME IN VERY PRETERM INFANTS ON NEUROSENSORY OUTCOME AT 2 YEARS OF AGE

Sponsor

Royal Women's Hospital, Melbourne

Enrollment

120 participants

Start Date

Jan 12, 2005

Study Type

Interventional

Conditions

SURVIVING VERY PRETERM INFANTS(<30 WEEKS' GESTATIONAL AGE)

Summary

Surviving infants < 30 weeks' gestational age will be randomly alloacted to a developmental care package delivered in the home or to standard follow-up care over the first year of life. The major endpoint is the Mental Developmental Index on the Bayley Scales of Infant Devlopment at 2 years of age, corrected for prematurity

Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 30 Weekss

Inclusion Criteria1

Surviving infants < 30 weeks' gestational age at birth.

Exclusion Criteria1

Recognisable congenital anomaly or chromosomal disorder universally associated with adverse developmental outcome.

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Interventions

Developmental care administered in the home to surviving infants born < 30 weeks' gestational age by a physiotherapist and a psychologist over the first year of life.

Locations(1)

VIC, Australia

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ACTRN12605000492651